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

Model Number 60081L

Device Problem Detachment Of Device Component (1104)

Patient Problems Eye Injury (1845); Capsular Bag Tear (2639); Vitrectomy (2643)

Event Date 03/15/2018

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

Reportedly, the cannula detached from the syringe during surgery caused a tear.It was also stated that the nucleus dropped into the vitreous fluid, which led to a retina consult.Additional information about this and other possible cases was requested but was not received.

Manufacturer Narrative

The device was returned to bausch + lomb.Product evaluation found the syringe was fully loaded and full of solution.The cannula was fully seated into the luer lock and was tight.No visible dried solution between the cannula hub and the threads of the luer lock.With much hand pressure force applied, the cannula did not shoot off or become separated from the luer lock connector.Therefore, the reported event could not be confirmed.The device history records (dhr) were reviewed and there were no non-conformities or anomalies related to the reported event.Based on available information, a root cause for the reported event could not be determined.

Event Description

Reportedly, the cannula came off while the surgeon was injecting viscoelastic into the eye.The cannula penetrated the posterior capsule and caused it to rupture.Vitrectomy was performed and the patient required treatment by a retinal surgeon.Current patient prognosis was described as ¿patient¿s vision is 20/25 with full recovery.¿.

• Brand Name: AMVISC PLUS VISCOSURGICAL DEVICE
• Type of Device: AID, SURGICAL, VISCOELASTIC
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): LIFECORE BIOMEDICAL; 3515 lyman blvd.; chaska MN 55318
• Manufacturer Contact: tes proud ; 1400 north goodman street; rochester, NY 14609 ; 5853388549
• MDR Report Key: 7430105
• MDR Text Key: 105443031
• Report Number: 0001313525-2018-00083
• Device Sequence Number: 1
• Product Code: LZP
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P810025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/31/2019
• Device Model Number: 60081L
• Device Catalogue Number: 59081L
• Device Lot Number: 026946
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2017
• 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
• Patient Outcome(s): Other