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U.S. Department of Health and Human Services

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

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BAUSCH + LOMB AMVISC PLUS VISCOSURGICAL DEVICE AID, SURGICAL, VISCOELASTIC Back to Search Results
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.

 
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Brand NameAMVISC PLUS VISCOSURGICAL DEVICE
Type of DeviceAID, 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 Key6464058
MDR Text Key71880979
Report Number0001313525-2017-02381
Device Sequence Number1
Product Code LZP
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP810025
Number of Events Reported1
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
Date FDA Received04/06/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator
Device EXPIRATION Date08/31/2017
Device MODEL Number60081
Device LOT NumberD140074A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/19/2017
Was Device Evaluated By Manufacturer? No
Date Device Manufactured10/30/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/06/2017 Patient Sequence Number: 1
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