MAUDE Adverse Event Report: BAUSCH + LOMB AMVISC PLUS VISCOSURGICAL DEVICE; AID, SURGICAL, VISCOELASTIC

Model Number 60081L

Device Problem Detachment of Device or Device Component (2907)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 08/17/2020

Event Type  malfunction  

Manufacturer Narrative

According to the reporter, the product is not available for evaluation.The investigation is ongoing.

Event Description

Case 6 of 10.It was reported that the viscoelastic hub had blown after it was screwed into the cannula.This was noticed the second time the viscoelastic was used during surgery while dispensing to insert the intraocular lens (iol).The viscoelastic was removed and replaced once it was noticed.The reporter indicated that nine similar incidents had occurred at the facility over the last three months.The account indicated the safety guide that was recently added to the product is not used and never will due to time constraints.

Event Description

Case 6 of 10.It was reported that during the use of the viscoelastic, there was patient contact, but no injuries were sustained from the broken viscoelastic hub/vial.There were no sutures used.

Manufacturer Narrative

The investigation is ongoing.

Manufacturer Narrative

A batch record review of the lot was performed.There were no deviations or comments within the manufacturing batch record that would result in the observed complaints.Final product testing for viscosity and extrusion force are within specification.No similar events have been reported for this product lot to date.The lot history, trend analysis, risk analysis, and directions for use are considered acceptable with the product performing within anticipated rates.No root cause related to the manufacturing process could be identified.No corrective action is necessary at this time.

• Brand Name: AMVISC PLUS VISCOSURGICAL DEVICE
• Type of Device: AID, SURGICAL, VISCOELASTIC
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• MDR Report Key: 10553564
• MDR Text Key: 207533641
• Report Number: 0001313525-2020-00137
• Device Sequence Number: 1
• Product Code: LZP
• Combination Product (y/n): Y
• PMA/PMN Number: P810025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: 60081L
• Device Catalogue Number: 60081L
• Device Lot Number: 028503
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 08/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1