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

Model Number LI61AOR

Device Problem Bent (1059)

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

Event Date 05/08/2018

Event Type  Injury  

Manufacturer Narrative

Investigation of this event is in progress.A follow-up report will be submitted upon completion of the investigation.

Event Description

It was reported that a lens haptic was found to be crushed during surgery, after implantation into the eye.As a result, the incision was enlarged in order to remove the lens and a same model lens was implanted with no issue.Patient was taken to recovery room in good condition.

Manufacturer Narrative

The lens was returned for evaluation.Visual inspection found both haptics bent.A device history record (dhr) review did not find any nonconformities or anomalies related to this complaint.Based on the information provided, the root cause cannot be determined.However, it is likely that the user related factors and/or procedural factors may have caused or contributed to the event.

• 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: 7575342
• MDR Text Key: 110291525
• Report Number: 0001313525-2018-00114
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 05/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/30/2022
• Device Model Number: LI61AOR
• Device Catalogue Number: LI61AOR2000
• Device Lot Number: 4757125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2017
• 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
• Treatment: EZ-28V DELIVERY DEVICE
• Patient Outcome(s): Other
• Patient Age: 77 YR