MAUDE Adverse Event Report: BAUSCH + LOMB SOFPORT AO INTRAOCULAR LENS

Model Number LI61AOR

Device Problem Kinked (1339)

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

Event Date 05/31/2018

Event Type  Injury  

Manufacturer Narrative

The lens was not returned for evaluation.A device history record (dhr) review did not find any nonconformities or anomalies related to this complaint.Based on the available information a root cause for this report event could not be determined.

• Brand Name: SOFPORT AO 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: tes proud ; 1400 north goodman street; rochester, NY 14609 ; 5853388549
• MDR Report Key: 7650875
• MDR Text Key: 119973020
• Report Number: 0001313525-2018-00127
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P910061
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/31/2021
• Device Model Number: LI61AOR
• Device Catalogue Number: LI61AOR2000
• Device Lot Number: 4647806
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other