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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON - COUVREUR N.V./ALCON - BELGIUM DUOVISC VISCOELASTIC SYSTEM; AID, SURGICAL, VISCOELASTIC

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ALCON - COUVREUR N.V./ALCON - BELGIUM DUOVISC VISCOELASTIC SYSTEM; AID, SURGICAL, VISCOELASTIC Back to Search Results
Catalog Number 8065571000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Corneal Edema (1791); Endophthalmitis (1835); Inflammation (1932)
Event Date 07/29/2020
Event Type  Injury  
Manufacturer Narrative
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 healthcare professional reported that a patient experienced endophthalmitis postoperatively.The patient was hospitalized and was started on ongoing antibiotic and corticosteroid treatment; the patient has since experienced a gradual decrease in inflammation and corneal edema.A vitrectomy was performed for vitreous sampling.All the culture samples came back negative.The facility has cancelled all ophthalmic procedures since (b)(6) 2020.
 
Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
 
Manufacturer Narrative
There was no sample returned for evaluation.The chemical lab tested a reference sample on ph and osmo and all tests are conform the specifications for the tested parameters.Batch records were reviewed and all testing results met specifications for this lot code at the time of release.Additionally, there were no deviations noted during batch record review.As no manufacturing related issues were identified, reference sample is conform the specifications for the tested parameters and no sample is available, a conclusive root cause could not be determined.All batches are released according to the required specifications.As no product is returned and/or insufficient product data is available, the complaint could not be verified and therefore no corrective and preventive action (capa) is initiated.However further trending is performed.The manufacturer internal reference number is: (b)(4).
 
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Brand Name
DUOVISC VISCOELASTIC SYSTEM
Type of Device
AID, SURGICAL, VISCOELASTIC
Manufacturer (Section D)
ALCON - COUVREUR N.V./ALCON - BELGIUM
rijksweg 14
puurs B-287 0
BE  B-2870
MDR Report Key10470068
MDR Text Key204894226
Report Number3002037047-2020-00021
Device Sequence Number1
Product Code LZP
Combination Product (y/n)N
PMA/PMN Number
P840064
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup,Followup
Report Date 12/03/2020
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? No
Device Operator Health Professional
Device Expiration Date10/31/2022
Device Catalogue Number8065571000
Device Lot Number20A22LA
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/05/2020
Initial Date FDA Received08/31/2020
Supplement Dates Manufacturer Received09/01/2020
11/17/2020
Supplement Dates FDA Received09/03/2020
12/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
BALANCED SALT SOLUTION; BVI CAPSULORHEXIS FORCEPS; CLEARCUT HP2 DB SLIT 2.2MM ANG; CUSTOM-PAK SURGICAL PROCEDURE PACK; DUOVISC; PHYSIOL MICROPURE HYDROPHOBE; STELLARIS; STELLARIS CASSETTE; BALANCED SALT SOLUTION; BVI CAPSULORHEXIS FORCEPS; CUSTOM-PAK SURGICAL PROCEDURE PACK; PHYSIOL MICROPURE HYDROPHOBE; STELLARIS; STELLARIS CASSETTE
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age77 YR
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