MAUDE Adverse Event Report: BAUSCH + LOMB AKREOS INTRAOCULAR LENS

Model Number AO60

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

Patient Problem Toxic Anterior Segment Syndrome (TASS) (4469)

Event Type  Injury  

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.

Event Description

An online article reported a series of case studies to assess the safety of scleral fixation using the akreos ao60 intraocular lens (iol) and gore-tex suture.The patient underwent a scleral fixation of the iol with gore-tex.Toxic anterior segment syndrome (tass) was seen in one eye one day post-op.The patient was given intravitreal antibiotic injection + dexa iv.Tass resolved on day post of and the patient achieved a final bcva of 20/40.The article reports scleral fixation with an akreos ao60 and gore-tex appears generally safe.

• 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: 15685478
• MDR Text Key: 302564837
• Report Number: 0001313525-2022-00157
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 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