MAUDE Adverse Event Report: BAUSCH + LOMB BAUSCH + LOMB VIS100 INJECTOR SYSTEM; FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)

Model Number VIS100

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

Patient Problem Corneal Edema (1791)

Event Date 12/12/2018

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 after the lens was implanted in the left eye, the surgeon realized that one of the haptics was broken.The lens was removed and intraoperatively replaced with a backup lens of the same model and power.Reportedly, the incision was enlarged to remove the lens and sutures were required.Following the completed surgery, the patient developed corneal edema and is continuing with prescribed post-op medication.

Manufacturer Narrative

The delivery device was not returned to bausch + lomb; therefore, a product evaluation could not be performed.The device history record (dhr) was reviewed and there were no discrepancies or deviations found that related to the reported issue.Based on available information, a root cause for the reported event could not be conclusively determined.However, user related factors (such as loading or handling techniques) and/or procedural factors (such as lens and inserter interaction) might have contributed to the event.

• Brand Name: BAUSCH + LOMB VIS100 INJECTOR SYSTEM
• Type of Device: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• MDR Report Key: 8232170
• MDR Text Key: 132567492
• Report Number: 0001313525-2019-00010
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): Y
• PMA/PMN Number: K133146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: VIS100
• Device Lot Number: 1820C9
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/09/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AKREOS ADVANCED OPTICS IOL.
• Patient Outcome(s): Other
• Patient Age: 77 YR