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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 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. ¿.

 
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Brand NameAMVISC PLUS VISCOSURGICAL DEVICE
Type of DeviceAID, 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 Key7430105
MDR Text Key105443031
Report Number0001313525-2018-00083
Device Sequence Number1
Product Code LZP
Combination Product (Y/N)Y
Reporter Country CodeUS
PMA/PMN NumberP810025
Number of Events Reported1
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 Received04/13/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator
Device EXPIRATION Date08/31/2019
Device MODEL Number60081L
Device Catalogue Number59081L
Device LOT Number026946
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/02/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/07/2018
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 04/13/2018 Patient Sequence Number: 1
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