Alcon Research, LLC: Medical Device Recall in 2022 - (Recall #: Z-1373-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Alcon Custom Pak Surgical Procedure Pack: 16998-11 2519351H SALAHUDDIN 2.4 PACK FRESNO SURGICAL HOSP 18392-03 14HDFF CATARACT SWAGEL WOOTTON EYE INSTITUTE 18527-03 14JM57 DOSS CATARACT ALLIANCE EYE SURG PARTNERS 11802-07 14KFAF GANS BASIC PACK NOVAMED EYE SURG CTR 11802-07 14LTRW GANS BASIC PACK NOVAMED EYE SURG CTR 11802-07 14LLME GANS BASIC PACK NOVAMED EYE SURG CTR 14429-07 14HPW3 DR SIEMINSKI CATARACT W NY CTR/AMB SVCS

Product Classification:

Class II

Date Initiated: June 9, 2022

Date Posted: July 20, 2022

Recall Number: Z-1373-2022

Event ID: 90437

Reason for Recall:

Due to latex gloves being include in Custom Pak. Kits are supposed to include non-latex gloves.

Status: Ongoing

Product Quantity: 320 kits

Code Information:

Pak #/Batch # / UDI Code 16998-11 / 2519351H / (01)10380651677385(10)2519351H(17)230331(30)3 18392-03 / 14HDFF / (01)10380651665238(10)14HDFF(17)221231(30)4 18527-03 / 14JM57 / (01)10380651684406(10)14JM57(17)240630(30)5 11802-07 / 14KFAF / (01)10380653423096(10)14KFAF(17)240430(30)5 11802-07 / 14LTRW / (01)10380653423096(10)14LTRW(17)240430(30)5 11802-07 / 14LLME / (01)10380653423096(10)14LLME(17)240430(30)5 14429-07 / 14HPW3 / (01)10380651666433(10)14HPW3(17)240229(30)6

Distribution Pattern:

U.S.: AZ, CA, MO, and NY O.U.S.: None

Voluntary or Mandated:

Voluntary: Firm initiated