MAUDE Adverse Event Report: BAUSCH + LOMB AKREOS INTRAOCULAR LENS

Model Number AKREOS AO60

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Retinal Detachment (2047)

Event Type  Injury  

Event Description

An online article reported a series of case studies to determine the long-term anatomic outcomes and surgical complications of pars plana vitrectomy (ppv) and 4-point gore-tex-sutured akreos ao60 intraocular lens (iol) scleral fixation.Two patients developed retinal detachments and needed an additional vitrectomy.The patient has a previous history of retinal detachment and corneal transplantation; a combined penetrating keratoplasties and ppvs because of retinal detachments and failure of corneal transplantation in which silicone oil was used as a tamponade agent.The results of the study demonstrated that this surgical technique is well tolerated by the eyes, with a low complication rate in the long term.The author of the article reported the lens remained implanted until the final chart revision.It is unknown if there was an iol exchange.No further information is available.This report is for patient 2 out of 2 who had retinal detachment.

Manufacturer Narrative

The device was not returned for evaluation.The trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.As a lot number was not provided, a dhr (device history record) review could not be performed.Based on all the available information, a root cause could not be determined.

• Brand Name: AKREOS INTRAOCULAR LENS
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; 21 north park place blvd.; clearwater FL 33759
• Manufacturer Contact: shayan habibi ; 21 north park place blvd.; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 15674085
• MDR Text Key: 302426171
• Report Number: 0001313525-2022-00154
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P060022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AKREOS AO60
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention