Alcon Research LLC: Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Vitrectomy Procedure Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Soft

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: 198205 Lot/code info: Lot Code: Many - See 'Attachment 1 - Affected Product List' Product Description: 25+ TOTALPLUS CP PAK 20K CPM BWV .9 IU Catalog Number: 8065000093 UDI-DI code: 380650000934 Lot Numbers: 177FE4 1782JM 178DEX 178TCV 179EP4 179EP3 179U0P 17AVMM 17AVMN 17AVML 17AVMP Product Description: 25+ TOTALPLUS CP PAK 20K CPM BV .9 IU Catalog Number: 8065000095 UDI-DI code: 380650000958 Lot Numbers: 1782JU 1782JT 178DF2 178TCY 178TD0 1792YF 1792YE 179U0R 17A4XT 17A4XU 17AFXT 17AVMT 17AVMU 17AVMV 17AVMW 17AVMX 17CNVC Product Description: 27+ TOTALPLUS CP PAK 20K CPM BV .9 IU Catalog Number: 8065000096 UDI-DI code: 380650000965 Lot Numbers: 1782JV 178DF4 17A4XV Product Description: TOTAL PLUS,23G,10K VALVE STD Catalog Number: 8065752435 UDI-DI code: 380657524358 Lot Numbers: 1754N7 1754NC 175M43 1762KH 176CCJ 176CCK 176WU8 176WU9 17769X 1782HM 1782HN 178T9K 179EEV 179TY3 179TY4 17A4WX 17C7FM 17C7FL Product Description: TOTAL PLUS,23GA,10K VALVE WD Catalog Number: 8065752436 UDI-DI code: 380657524365 Lot Numbers: 1762KJ 176WUA 17769Y 177FDH 1782HP 178DE8 178T9N 179EEX 179EEY 17C7FK Product Description: TOTAL PLUS,25+,10K VALVE STD Catalog Number: 8065752437 UDI-DI code: 380657524372 Lot Numbers: 1754NK 1754NL 1754NM 1754TC 1754TD 1754TE 1754TF 1754TH 175M45 175M46 175M47 175M44 1762KK 1762KL 1762KM 1762KN 176CCR 176CCL 176CCM 176CCN 176CCP 176WUD 1776A4 1776A5 1776A6 177FDJ 177FDK 177FDL 177FDM 177TUP 177TUR 177TUT 1782HU 1782HV 1782HW 178DEA 178DEC 178T9V 178T9W 178TD4 17930F 17930H 179EF3 17

UPC codes

380650000934, 380650000958, 380650000965, 380657524358, 380657524365, 380657524372, 380657524389, 380657524396, 380657524495, 380657524501, 380657524518, 380657531066, 380657531097, 380658300777

Source

Official record: FDA (Device enforcement) ↗

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