MAUDE Adverse Event Report: BAUSCH & LOMB INCORPORATED CATARACT EYE LENS; INTRAOCULAR LENS

Model Number MI60L

Device Problem Defective Component (2292)

Patient Problem Insufficient Information (4580)

Event Date 08/26/2021

Event Type  Injury  

Event Description

Have a defective cataract lens that has blurred my vision because of calcification of the lens.My eye doctor has never seen this in a patient and only read about it in text book.Very rare condition.Fda safety report id# (b)(4).

• Brand Name: CATARACT EYE LENS
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): BAUSCH & LOMB INCORPORATED
• MDR Report Key: 12638972
• MDR Text Key: 276914346
• Report Number: MW5104654
• Device Sequence Number: 1
• Product Code: HQL
• 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: 10/12/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MI60L
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/14/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 113