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

Catalog Number	0005710057
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2021
Type of Reportable Event	Serious Injury
Additional 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.This is the third of seven reports for this reported event.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported an "outbreak" of tass at their facility.In a follow up with the customer, it was reported that there were four patients who presented with tass following ocular surgery.There were two surgeons involved.All four patients associated with this report of tass had a history of glaucoma.The exact procedure performed on any one patient remains unconfirmed.This file represents one of the four patients.
Additional Manufacturer Narrative
There was no sample returned for evaluation.Our lab has tested retain samples of the associated product lot and all results were conforming to the specifications for the tested parameters (ph, osmolality, lal).Complaint trending was reviewed for the lot code provided.Two similar complaints were found.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 the batch record review.As no manufacturing related issues were identified, retain samples are conforming the specifications and no sample is available, a conclusive root cause could not be determined.All batches are released according to the required specifications.Based on the complaint information and the investigation results, we can conclude that the disposition of the product remains unchanged.As no product is returned and/or insufficient product data is available, the complaint could not be verified and therefore no capa is initiated.However further trending is performed.The manufacturer internal reference number is: (b)(4).

• Brand Name: DUOVISC VISCOELASTIC SYSTEM
• Common Device Name: AID, SURGICAL, VISCOELASTIC
• Manufacturer (Section D): ALCON - COUVREUR N.V./ALCON - BELGIUM; rijksweg 14; puurs B-287 0; BE B-2870
• MDR Report Key: 11711069
• Report Number: 3002037047-2021-00007
• Device Sequence Number: 16928547
• Product Code: LZP
• UDI-Device Identifier: 00380651999077
• UDI-Public: 00380651999077
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P840064
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 0005710057
• Device Lot Number: 20F30IA
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/31/2021
• Supplement Date Received by Manufacturer: 06/14/2021
• Initial Report FDA Received Date: 04/22/2021
• Supplement Report FDA Received Date: 06/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other