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

Model Number 60081L

Device Problem Failure to Align (2522)

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

Event Date 08/12/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned for evaluation.The investigation is underway.

Event Description

It was reported that the luer lock is coming out of position and the viscoelastic is leaking through the syringe instead of cannula.No patient impact/outcome information was provided.Though requested, no additional information has been received.

Manufacturer Narrative

The product evaluation has been complete.Visual inspection found the retention clip not properly attached to the nearly full syringe.A tip cap protector had been placed over the cannula.The needle was bent.There was dried solution visible under the lure lock connector at the tip of the glass syringe barrel.The cause of the leak cannot be determined.Additional investigation is underway.

Event Description

According to the reporter, the patient was not harmed.

Manufacturer Narrative

Further evaluation of the returned device was performed.After attempted extrusion the product would not come through the provided cannula, but leaked through the threaded area of the luer lock/cannula interface.A batch record review of the product lot was performed.There were no deviations or comments within the manufacturing batch record that would result in the observed event.No similar events have been reported for this product lot.Based upon the product trend review, the volume of complaints is within the acceptable control limits and no trend is observed.No root cause related to the manufacturing process could be identified for the product lot based on the review of the batch record and receiving inspection reports.Final product testing for viscosity and extrusion force were within specification.The investigation shows that the raw material syringes and cannulas used were found to be acceptable and that the final product lot meets the product specifications.Final product testing requires the connection of the cannula to the syringe for expelling product used in testing activities.Record review determined there were no deviations or comments regarding cannula performance or product flow.The lot history, trend analysis, risk analysis and directions for use review are considered acceptable, with the product performing within anticipated rates.No corrective action is necessary at this time.

Event Description

According to the reporting surgeon, the event occurred during procedure yet there was no patient contact.The safety guard did not support the cannula tip attached to the product syringe.The cannula tip and safety guard both came off of the hub into the surgeon¿s hands.The product was not used.There was no effect on the patient and the patient is stable.

• Brand Name: AMVISC PLUS VISCOSURGICAL DEVICE
• Type of Device: AID, SURGICAL, VISCOELASTIC
• Manufacturer (Section D): BAUSCH + LOMB; 1400 n goodman; rochester NY 14609
• MDR Report Key: 10543483
• MDR Text Key: 207352484
• Report Number: 0001313525-2020-00125
• 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: 01/01/2005,08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: 60081L
• Device Catalogue Number: 60081L
• Device Lot Number: 028250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• 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: 08/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1