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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIFECORE BIOMEDICAL, LLC VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE AID, SURGICAL, VISCOELASTIC

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LIFECORE BIOMEDICAL, LLC VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE AID, SURGICAL, VISCOELASTIC Back to Search Results
Catalog Number 0004520066
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Intraocular Pressure Increased (1937); Reaction (2414)
Event Type  Injury  
Manufacturer Narrative

No sample has been received by manufacturing for evaluation. Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable information becomes available. The manufacturer internal reference number is: (b)(4).

 
Event Description

A physician reported that viscoelastic solution was used during surgery after which the patient presented, postoperatively, with unusual findings including possible toxic reaction, unspecified, and elevated intraocular pressure. The patient was surgically treated with two angle taps. Additional information has been requested.

 
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Brand NameVISCOAT OPHTHALMIC VISCOSURGICAL DEVICE
Type of DeviceAID, SURGICAL, VISCOELASTIC
Manufacturer (Section D)
LIFECORE BIOMEDICAL, LLC
3515 lyman boulevard
chaska MN 55318
Manufacturer (Section G)
LIFECORE BIOMEDICAL, LLC
3515 lyman boulevard
chaska MN 55318
Manufacturer Contact
jonathan schlech
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8175514979
MDR Report Key10189061
MDR Text Key201022281
Report Number2184002-2020-00001
Device Sequence Number1
Product Code LZP
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP840064
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 06/24/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/24/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number0004520066
Device LOT Number028148
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 Received06/08/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 06/24/2020 Patient Sequence Number: 1
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