FDAFDA · Alimentos y medicamentos·N.º oficial Z-1606-2024
Various Alcon Custom Paks Surgical Procedure Pack containing Oasis 27Ga Chang Hydrodissection Cannulas. These Custom Paks are surgical procedure packs used by ophthalmic surgeons in a variety of ophthalmic surgeries. The Custom Pak is a collection of various ophthalmic surgical instruments and necessary materials. Below are the various Alcon Customer Paks and Pak REF Numbers: 0515-66 ELMENDORF AFB CATARACT 3RD MED CTR 0752-74 CATARACT V A MED CTR 1119-82 DR DAVID B LEACH PALOUSE SURGERY CENTER 11401-13 CATARACT SUTTER SOLANO MED CTR 11910-32 DAVISON-SAGGAU CATARACT WOLFE EYE SURGER 11912-26 30 DEG CATARACT BASE PACK WOLFE EYE SUR 11913-23 JOHNSON CATARACT WOLFE EYE SURGERY CENTE 12185-14 CATARACT LASERVUE EYE CENTER 12213-12 CATARACT TULSA SPINE AND SPECIALTY 12213-13 CATARACT TULSA SPINE AND SPECIALTY 12213-15 CATARACT TULSA SPINE AND SPECIALTY 12213-16 CATARACT TULSA SPINE AND SPECIALTY 12643-06 CATARACT PACK OCHSNER BAPTIST MED CTR 12931-17 JOHNSON CATARACT GREATER COMMUNITY HOSP 12942-18 CONRAD PHYSICIANS MEDICAL CENTER 12942-19 CONRAD PHYSICIANS MEDICAL CENTER 13567-10 OPHTHALMIC PHYSICIANS SURG CTR 13948-15 DR RHEE PACK MARSHALLTOWN MED/SURG CNT 13970-11 CATARACT GWINNETT CTR OUTPT SURG 13970-12 CATARACT GWINNETT CTR OUTPT SURG 14389-08 INFINITI STAMFORD SURGICAL CENTER 14408-12 E-Z PACK QUEEN OF THE VALLEY 14408-13 E-Z PACK QUEEN OF THE VALLEY 14533-18 OPHTHALMIC UOFL HOSPITAL 15209-05 CATARACT NORTH ATLANTA EYE SURGERY CTR 15354-16 DR RAUEN WOLFE EYE SURGERY CENTER LLC 15435-13 EPS 2.2 PACK IOWA CITY AMBULATORY SURGER 15502-10 DR NEWCOMB LEXINGTON CLINIC 15639-12 DR RAUEN LUCAS COUNTY HEALTH CTR 15678-13 DR RAUEN CLARKE COUNTY HOSPITAL 15965-12 DR LEVAR CHRISTUS SANTA ROSA ASC 16001-12 DR YONKER/BESCAK CESC 16001-13 DR YONKER/BESCAK CESC 16013-12 DR MCDONALD NORTH FL SURG PAVILION 16086-07 DR DAVID B LEACH PULLMAN MEMORIAL HOSPIT 16177-08 OPHTHALMIC DENVER EYE SURG CTR 16204-13 CATARACT V A HOSPITAL 16450-10 DR GROSS/GUSSLER KINGS DAUGHTERS HOSPITA 16452-06 RAECKER PACK GREATER COMMUNITY HOSP 16633-08 CATARACT DUOVISC RETINA SPECIALISTS NJ 16644-08 DR BALES HOSPITAL PACK NATIVE INVESTMENT 16644-09 DR BALES HOSPITAL PACK NATIVE INVESTMENT 16798-08 CATARACT HAUSER ROSS EYE INSTITUTE 16820-06 PHACO LONE PEAK SURGERY CENTER 17029-09 DR ICON CATARACT DAY SURGERY OF GRAND JU 17201-18 SILVERA VALLEY SURGERY CENTER 17340-08 EPS 2.2 PACK WASHINGTON COUNTY HOSP 17354-07 EPS 2.2 PACK HENRY COUNTY HEALTH CTR 17361-08 MICRO PAK CARLE FOUNDATION HOSP 17382-05 CATARACT BILLINGS VA MEDICAL CENTE 17382-07 CATARACT BILLINGS VA MEDICAL CENTE 17507-02 DR CAMPAGNA NORTH CENTRAL METH ASC 17520-05 DR GROSS CHARLESTON SURGERY CTR 17526-09 CPK0926-CROSBY-DONG-GADLIN-JAC VANTAGE O 17529-09 CPK0927 AESC VANTAGE OUTSOURCING 17541-07 HAIDER DUPONT SURG CTR 17541-08 HAIDER DUPONT SURG CTR 17617-05 DR CHUNG CATARACT PACK ST HELENA HOSPITA 17651-06 DMEK-DSEK-CAT CENTER FOR ADVANCED SURGER 17653-06 DR HUNT CHARLESTON AREA MED CTR 17671-06 CATARACT EDMONDS CENTER FOR OUTPAT 17671-07 CATARACT EDMONDS CENTER FOR OUTPAT 17740-06 DR ESPANDAR ARMSTRONG CO MEM HOSP 17740-07 DR ESPANDAR ARMSTRONG CO MEM HOSP 17740-08 DR ESPANDAR ARMSTRONG CO MEM HOSP 17773-09 DR ESPANDAR JAMESON MEMORIAL HOSPITAL 17930-08 CATARACT PACK NORTHERN PLAINS SURG CTR 17966-06 TURNER CATARACT WOLFE EYE SURGERY CENTER 17987-05 OPHTHALMIC SEATTLE SURGERY CENTER 18069-04 DR WENTWORTH CATARACT GREENVIEW SURGERY 18123-05 CATARACT BOWERS INNOVATIVE EYE SURGERY C 18208-09 CATARACT SUTTER FAIRFIELD SURG CTR 18382-04 DR GEORGE ZAMBELLI BEAVER VALLEY ASC 18382-06 DR GEORGE ZAMBELLI BEAVER VALLEY ASC 18384-04 DR BURKS SPRINGHILL SURGERY CENTER 18401-04 MCGRAW SIGHTPATH MEDICAL 18406-03 DR KUCHINKA HAYWARD AREA HOSP 18427-07 CATARACT V A HOSPITAL 18427-08 CATARACT V A HOSPITAL 18431-06 VISION EYE SC VISION EYE SURGERY CENTER 18445-03 K LEE/LIN CALIFORNIA PACIFIC MED CT 18550-04 DR HU TORRES CAT & LSR CNTRL 18555-04 DR WU - CENTURION CAT & LSR CNTRL 18636-10 CATARACT BONNER GENERAL HOSPITAL
Publicado el 1 de mayo de 2024 · Inicio del retiro: 15 de marzo de 2024
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Due to complaints of particulates, residue, occlusions, and bent tips for sterile cannulas.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Alcon Research, LLC
- Distribuidor
- Worldwide distribution - U.S. Nationwide including in the states of AK, AR, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MT, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The countries of Australia, Canada, and New Zealand.
- Lote
- Pak Number/Product Desp/GTIN/UDI: 0515-66 ELMENDORF AFB CATARACT 3RD MED CTR 380655168448 H5301ALCON1CPAK10 Lot Numbers: JZ5201911 JZ5202956 0752-74 CATARACT V A MED CTR 380653425277 H5301ALCON1CPAK10 Lot Numbers: JZ5180248 JZ5181442 JZ5193970 JZ5199465 JZ5200775 16JYUR 1119-82 DR DAVID B LEACH PALOUSE SURGERY CENTER 380651661752 H5301ALCON1CPAK10 Lot Numbers: JZ5180968 15XVDX JZ5185253 JZ5186896 JZ5189654 JZ5194999 JZ5195815 JZ5200769 JZ5201588 11401-13 CATARACT SUTTER SOLANO MED CTR 380651681347 H5301ALCON1CPAK10 Lot Numbers: 160RRK 163XWD 165YVA 1681H3 169RYX 16A4UF 16KACN 11910-32 DAVISON-SAGGAU CATARACT WOLFE EYE SURGER 380655151587 H5301ALCON1CPAK10 Lot Numbers: 15UXH3 15W9DE 15XE9V 15YE10 1628K4 1646KW 1657E6 1687N8 169J7K 16AHR0 16D2VP 11912-26 30 DEG CATARACT BASE PACK WOLFE EYE SUR 380655158135 H5301ALCON1CPAK10 Lot Numbers: 15UWHC 15VAEH 15VWP3 15WC2N 15YJRJ 15YJT2 15YJTA 15YJTD 15YLT6 15YLT7 15YLV0 15YLWE 164R3F 1681HR 1683U4 1689KU 1689LH 169T02 16AUVP 16C497 16EE2D 16EE31 16EHCT 16JWXT 16KKDF 16KR3J 11913-23 JOHNSON CATARACT WOLFE EYE SURGERY CENTE 380655156513 H5301ALCON1CPAK10 Lot Numbers: 161CX3 164057 12185-14 CATARACT LASERVUE EYE CENTER 380651662698 H5301ALCON1CPAK10 Lot Numbers: 161HT2 166DNN 166DPV 167XAY 168J0C 16D31W 16FVYU 16JLLM 12213-12 CATARACT TULSA SPINE AND SPECIALTY 380655142332 H5301ALCON1CPAK10 Lot Numbers: JZ5180099 JZ5180703 JZ5182416 12213-13 CATARACT TULSA SPINE AND SPECIALTY 380655159736 H5301ALCON1CPAK10 Lot Numbers: JZ5194624 JZ5186533 JZ5190784 JZ5195054 12213-15 CATARACT TULSA SPINE AND SPECIALTY 380655167045 H5301ALCON1CPAK10 Lot Number: 16DY06 12213-16 CATARACT TULSA SPINE AND SPECIALTY 380655168899 H5301ALCON1CPAK10 Lot Numbers: 16JCD3 JZ5205295 16JYW4 12643-06 CATARACT PACK OCHSNER BAPTIST MED CTR 380655142530 H5301ALCON1CPAK10 Lot Numbers: JZ5179405 JZ5179791 JZ5179793 15UMDX JZ5183399 JZ5185544 161WC3 JZ5185546 164NV6 166CF1 166CF6 169K47 169VJC 16AYM1 16EP3E 16ERDY 16H78W 16H7A0 16JJ75 12931-17 JOHNSON CATARACT GREATER COMMUNITY HOSP 380655151082 H5301ALCON1CPAK10 Lot Numbers: 15VJUE 161A9X 12942-18 CONRAD PHYSICIANS MEDICAL CENTER 380655136058 H5301ALCON1CPAK10 Lot Number: 168F5E 12942-19 CONRAD PHYSICIANS MEDICAL CENTER 380655169681 H5301ALCON1CPAK10 Lot Number: 16F8PN 13567-10 OPHTHALMIC PHYSICIANS SURG CTR 380655148365 H5301ALCON1CPAK10 Lot Numbers: JZ5180061 15UTNR 15VP7K JZ5182727 JZ5183496 1641VT 164PYY 1664DR 166KMA 167VJ2 168PW9 169NKL 169NKN 16AUX1 16D31C 16D3EU 16ENFD JZ5200243 JZ5200239 JZ5201252 16FC7K 16FD6A 13948-15 DR RHEE PACK MARSHALLTOWN MED/SURG CNT 380651661653 H5301ALCON1CPAK10 Lot Numbers: 15V7VC 15YTL0 16EK48 16HV9P 16KTDN 16KV3J 13970-11 CATARACT GWINNETT CTR OUTPT SURG 380655153581 H5301ALCON1CPAK10 Lot Numbers: JZ5180411 JZ5180409 13970-12 CATARACT GWINNETT CTR OUTPT SURG 380655163511 H5301ALCON1CPAK10 Lot Numbers: JZ5195307 JZ5195305 16ACFA 16CW8X 16E005 16F3H9 JZ5201679 JZ5201681 JZ5202345 JZ5202347 16H4C7 16HCD2 14389-08 INFINITI STAMFORD SURGICAL CENTER 380653418811 H5301ALCON1CPAK10 Lot Numbers: 16ANV6 16EE39 14408-12 E-Z PACK QUEEN OF THE VALLEY 380651699090 H5301ALCON1CPAK10 Lot Numbers: 1637KP 163A2K 163A2L 1654AX 1694P1 16AAKP 14408-13 E-Z PACK QUEEN OF THE VALLEY 380655169865 H5301ALCON1CPAK10 Lot Number: 16J3V0 14533-18 OPHTHALMIC UOFL HOSPITAL 380655128893 H5301ALCON1CPAK10 Lot Numbers: 15TDRD JZ5187567 162V0V JZ5188305 1646L8 166KRH 167F66 1689PX JZ5196723 169Y7X JZ5196725 15209-05 CATARACT NORTH ATLANTA EYE SURGERY CTR 380655119266 H5301ALCON1CPAK10 Lot Numbers: JZ5182015 JZ5179828 JZ5182017 JZ5182019 JZ5182021 JZ5182023 JZ5182025 JZ5189545 JZ5189547 1683UH JZ5193687 JZ5193689 JZ5193693 JZ5193691 JZ5193695 JZ5194353 JZ5194347 JZ5194349 169624 169J38 16EJNU 16EK31 16EK3F 16ERDT 16F1Y8 16F5KY 16F5L7 16FU6F 16H79A 16HE8M 16HHPC 16HLN4 16KNX3 15354-16 DR RAUEN WOLFE EYE SURGERY CENTER LLC 380651669154 H5301ALCON1CPAK10 Lot Numbers: 15URRF 15VH42 15X4TK 163KMN 15435-13 EPS 2.2 PACK IOWA CITY AMBULATORY SURGER 380651
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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