—#196251

Product

BAUSCH + LOMB CATARACT PACK, REF VAL001CPMEA. Convenience kit used in surgical procedures.

FDA product code: OJK — Eye Tray
Device class: Class 2
Medical specialty: Ophthalmic
Affected lot / code info: GTIN (01) 10195327108168, Lot Number 22DBL466

Why it was recalled

Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Medline disseminated MEDICAL DEVICE RECALL notice by US mail on 09/30/2022, The notices explained the issue and requested the following: "REQUIRED ACTION: 1.Immediately check your stock for the affected item number and the affected lot numbers listed on the recall portal. Destroy affected product. 2.Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the form. The login for completing the response form is: Website link: https://recalls.medline.com Recall Reference #: R-22-149-FG Recall Code: RXXXXXXX 3.Upon completion of the form, please destroy affected product. Your account will receive credit once the response form is submitted. 4.If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Have the customers document and destroy any affected product. You should include your customers quantities on your response form. If you have any questions, please contact the Recall Department at 866-359-1704."

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: US Nationwide distribution in the states of CA, MN, NC, NY, OK, PA, TN, TX.

Timeline

Recall initiated: 2022-09-30
Posted by FDA: 2022-11-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #196251. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.