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

Model Number 60081

Device Problems Burst Container or Vessel (1074); Detachment Of Device Component (1104)

Patient Problem Zonular Dehiscence (2698)

Event Date 03/07/2017

Event Type  Injury  

Manufacturer Narrative

Investigation of this event is in progress.A follow-up will be submitted upon completion of the investigation.

Event Description

It was reported that the syringe "burst" while attempting to use it and the tip hit the patient's left eye zonules.The surgeon believed the zonules could no longer safely hold the intraocular lens, so the surgery was canceled.The patient was advised to come back the following day.It was stated that the patient would also be getting referred to a retinal specialist for the injury.

Manufacturer Narrative

The device was not returned for evaluation.A device history record (dhr) review did not find any nonconformities or anomalies related to this complaint.Based on the given information, the exact root cause could not be conclusively determined.

Event Description

Additional information received from the facility provided further details regarding this event.During preparation for surgery, it was noted that the patient appeared to have weak or loose zonules on the inferior side of the eye.It was also noted that the cataractous lens appeared to be slightly displaced.During surgery, as viscoelastic was being filled into the eye, the cannula detached from the hub, causing leakage.As a result of the detachment, the syringe hub then made contact with the lens as well.At this time, an area of absent zonules was then observed on the nasal side of the eye, in addition to the loose zonules from the inferior side.At this stage, it was determined that it was unsafe to proceed with the surgery.The viscoelastic was removed from the eye, the wound was closed, and the surgery was aborted.No further surgeries have taken place at this time.

• Brand Name: AMVISC PLUS VISCOSURGICAL DEVICE
• Type of Device: AID, SURGICAL, VISCOELASTIC
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): ANIKA THERAPEUTICS; 32 wiggins avenue; bedford MA 01730
• Manufacturer Contact: faranak gomarooni ; 50 technology drive west; irvine, CA 92618 ; 9493985708
• MDR Report Key: 6464058
• MDR Text Key: 71880979
• Report Number: 0001313525-2017-02381
• Device Sequence Number: 1
• Product Code: LZP
• Combination Product (y/n): N
• 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,other
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 03/08/2017

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?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/31/2017
• Device Model Number: 60081
• Device Lot Number: D140074A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2017
• Initial Date FDA Received: 04/06/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/16/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/30/2014
• 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