Alcon Research LLC: Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Alc

Hazard

Due to the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area of the lidding. While the damage in the lidding is visibly noticeable, due to risk of sterility being compromised.

Details from the source

Reason for recall: Due to the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area of the lidding. While the damage in the lidding is visibly noticeable, due to risk of sterility being compromised. Distribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. The countries of Albania, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Brazil, Bulgaria, Cambodia, Canada, Chile Quantity: 15557 kits Lot/code info: Lot Code: Many - See 'Attachment 1 - Affected Product List' Catalog Number / Lot Number / Custom Pak Description/ UDI-DI code: 0094-77 17C3H9 J-CAT PAK - CVS KENRITSU NINOHE HP 380655137888 10366-13 17CY90 AUS-CATARACT BRISBANE WATERS 380655161951 10924-15 176JX0 25G VIT 25G OPTICARE EYE HLTH CTR 380651690714 11201-11 17A18R AUS-DR CH KHONG ST JOHN OF GOD GERALDTON 380655184899 11201-11 17A1AW AUS-DR CH KHONG ST JOHN OF GOD GERALDTON 380655184899 11220-27 176NYN VITRECTOMY 25G NORTHSIDE HOSP 380655178492 11220-27 1772HN VITRECTOMY 25G NORTHSIDE HOSP 380655178492 11220-27 1772L9 VITRECTOMY 25G NORTHSIDE HOSP 380655178492 11220-27 177URH VITRECTOMY 25G NORTHSIDE HOSP 380655178492 11220-27 179TKU VITRECTOMY 25G NORTHSIDE HOSP 380655178492 11220-27 17CF2K VITRECTOMY 25G NORTHSIDE HOSP 380655178492 11220-27 17AMJJ VITRECTOMY 25G NORTHSIDE HOSP 380655178492 11220-27 17AMMW VITRECTOMY 25G NORTHSIDE HOSP 380655178492 11220-27 17CLCN VITRECTOMY 25G NORTHSIDE HOSP 380655178492 11220-27 179Y3T VITRECTOMY 25G NORTHSIDE HOSP 380655178492 1137-65 17A46H CATARACT FRENCH HOSP CORP 380653436938 1137-65 17CXY9 CATARACT FRENCH HOSP CORP 380653436938 12568-09 178PTE 23G CONSTELLATION NORTHERN MICH SPPLY AL 380653414561 12568-09 17CK02 23G CONSTELLATION NORTHERN MICH SPPLY AL 380653414561 12641-14 178KD6 AUS-25GA VIT RET BRISBANE WATERS 380655181935 12852-16 179N1E AUS-23GA 10K COMBINED VR PAK NEW CHILDRE 380655158425 13110-11 17AKR3 23GA CVS RETINA TPP V A HOSP HOUSTON 380655177549 13501-08 177D

UPC codes

380655137888, 380655161951, 380651690714, 380655184899, 380655178492, 380653436938, 380653414561, 380655181935, 380655158425, 380655177549, 380653441505, 380655155912, 380655164570, 380655164433, 380653432602, 380655123829, 380655141953, 380655191378, 380655187586, 380655116074, 380655160046, 380651696402, 380651674882, 380651696419, 380655156094, 380655183243, 380655181980, 380655178928, 380651696464, 380655114452, 380651697027, 380655191385, 380655199497, 380655138113, 380653441703, 380655196595, 380655181997, 380651638211, 380651638228, 380651697386

Source

Official record: FDA (Device enforcement) ↗

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