MAUDE Adverse Event Report: BAUSCH & LOMB INCORPORATED SOFLENS 38; LENSES, SOFT CONTACT, EXTENDED WEAR

Catalog Number CE0050

Event Date 11/27/2023

Event Type  malfunction  

Event Description

I recently had an eye exam and re upped my contact lens prescription.I've worn this particular lens for a number of years, i know them well.The latest batch of lens has a problem and i believe the problem is with the contact solution the new lenses are packaged with.Brand new the lenses come out of the package tightly wrapped up on its self.The first one i literally could not get to open up, with the second lens i observed the same condition.This lens i finally opened up and it had a huge line in it where it was folded up on its self.When i placed these damaged lens in my contact solution they released and opened up.I question if the factory contact solution is safe and would like to have the unopened lens tested to see if the solution is safe.The third pair of lenses opened up easier so i put them in but they seemed to bother my eyes considering they were brand new, this should not happen.The lens in question are bausch and lomb soflens 38.I understand these lens are going to be phased out.There have been no tests done at this point.Reference reports: mw5148657, mw5148658.

• Brand Name: SOFLENS 38
• Type of Device: LENSES, SOFT CONTACT, EXTENDED WEAR
• Manufacturer (Section D): BAUSCH & LOMB INCORPORATED
• MDR Report Key: 18255539
• MDR Text Key: 329898682
• Report Number: MW5148659
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 07/14/2023
• Device Catalogue Number: CE0050
• Device Lot Number: Y21907041
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/01/2023
• Patient Sequence Number: 1
• Treatment: AMLODIPINE.; HYDROCHLOROTHIAZIDE.; LISINOPRIL.; OSTEO BI-FLEX.; PROSTATE PLUS HEALTH COMPLEX.
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 107 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White