Alcon Research, LLC: Various Alcon Custom Paks Surgical Procedure Pack containing Oasis 27Ga Chang Hydrodissection Cannulas. These Custom Paks are surgical procedure packs used by ophthalmic surgeons

Hazard

Due to complaints of particulates, residue, occlusions, and bent tips for sterile cannulas.

Details from the source

Reason for recall: Due to complaints of particulates, residue, occlusions, and bent tips for sterile cannulas. Distribution: 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. Quantity: 57,352 cannulas Lot/code info: 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

UPC codes

380655168448, 380653425277, 380651661752, 380651681347, 380655151587, 380655158135, 380655156513, 380651662698, 380655142332, 380655159736, 380655167045, 380655168899, 380655142530, 380655151082, 380655136058, 380655169681, 380655148365, 380651661653, 380655153581, 380655163511, 380653418811, 380651699090, 380655169865, 380655128893, 380655119266, 380651669154, 380651696761, 380651659216, 380651662247, 380651661172, 380655147849, 380655139660, 380655171158, 380651674004, 380651661769, 380655157817, 380651672123, 380651700826, 380655147382, 380655126097

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.