MAUDE Adverse Event Report: BAUSCH AND LOMB INC (LI61AO; BAUSCH AND LOMB) IOL LENS; INTRAOCULAR LENS

Model Number LI61AO

Device Problem Device Slipped (1584)

Patient Problems Pain (1994); Visual Impairment (2138); Patient Problem/Medical Problem (2688)

Event Date 08/28/2018

Event Type  Injury  

Event Description

Serial no (b)(4) iol lens model, (li61ao; bausch & lomb) for cataract was implanted and have had diminish sight ever since to include partial blindness.Have had to see three other medical specialists since.The lens is claimed by surgeon to have slipped out of place.Have had severe eye pain since (b)(6).

• Brand Name: (LI61AO; BAUSCH AND LOMB) IOL LENS
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): BAUSCH AND LOMB INC
• MDR Report Key: 7999396
• MDR Text Key: 125101390
• Report Number: MW5080759
• Device Sequence Number: 1
• Product Code: HQL
• 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: 10/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LI61AO
• Device Lot Number: 4841905
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Age: 59 YR
• Patient Weight: 83