MAUDE Adverse Event Report: BAUSCH + LOMB ULTRA CONTACT LENSES WITH MOISTURE SEAL TECHNOLOGY

Lot Number R62007077

Device Problem Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/16/2017

Event Type  malfunction  

Event Description

I have been wearing bausch + lomb ultra contact lenses for quite some time.Within the last 6 pack box that i ordered from (b)(6), two of the four lenses that i have used so far have ripped in half during regular use.I have the packaging and will send you the lot, serial number, barcodes, etc if you need them.

• Brand Name: ULTRA CONTACT LENSES WITH MOISTURE SEAL TECHNOLOGY
• Type of Device: CONTACT LENSES
• Manufacturer (Section D): BAUSCH + LOMB
• MDR Report Key: 6653093
• MDR Text Key: 78058727
• Report Number: MW5070505
• Device Sequence Number: 1
• Product Code: LPL
• 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: 06/16/2017

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 Operator: Lay User/Patient
• Device Expiration Date: 05/22/2019
• Device Lot Number: R62007077
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/16/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 59