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

Model Number 59081L

Device Problems Failure to Align (2522); No Apparent Adverse Event (3189)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

According to the reporter, no additional information is available for this case.The product lot number is unknown, and the product is not available for evaluation.The investigation is ongoing.

Event Description

A surgeon reported an incident where the product cannula injected viscoelastic into the anterior chamber during surgery.The cannula had come off the syringe.There was no patient injury.The reporting facility indicated that no further information is available for this case and the product lot number is unknown.

Manufacturer Narrative

Additional information to g4, h2, h6, h10/11.The product was not returned for evaluation; consequently, no product evaluation was performed.A dhr (device history record) review could not be done as no lot number has been provided.The trend analysis, risk analysis and directions for use review are considered acceptable, with the product performing within anticipated rates.Six similar incidents have been reported within the last two years.A manufacturing-related root cause has never been identified and no patient injury has occurred for the similar reported incidents.In august 2019 safety guards were added to this product.As the lot number related to this event is unknown, it is unclear if this product had a safety guard.No corrective action is necessary of this time.

• Brand Name: AMVISC VISCOSURGICAL DEVICE
• Type of Device: AID, SURGICAL, VISCOELASTIC
• Manufacturer (Section D): BAUSCH + LOMB; 1400 n. goodman; rochester NY 14609
• MDR Report Key: 9667060
• MDR Text Key: 177772918
• Report Number: 0001313525-2020-00025
• 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
• Report Date: 01/01/2005,01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 59081L
• Device Catalogue Number: 59081L
• Device Lot Number: UNKNOWN
• 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: 04/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1