MAUDE Adverse Event Report: ALCON - COUVREUR N.V./ALCON - BELGIUM VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE; AID, SURGICAL, VISCOELASTIC

Catalog Number	8065183150
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample is available that has not yet been received at 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 or Problem Description
A customer reported that a viscoelastic product was used during cataract surgery after which a fiber was noted inside of the eye upon the first post-operative follow-up.The retained fiber had to be removed from the eye on a later date.Currently, no patient harm is reported.
Additional Manufacturer Narrative
Complaint trending reviewed for the lot code provided.No similar complaint found.The provided photo shows an assembled viscoelastic syringe which is completely used.No material deviations to the components observed related to this complaint.One folding box and one assembled viscoelastic syringe which was completely used were received as a complaint sample.There is an extra glass carrier plate on which a particle is included.Since the sample has been opened and used up, the origin of the particle cannot be traced.Based on the analysis of the particle lab the particle consists of cellulose and protein.The sample during final inspection was visually checked and okay with no foreign material observed.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.A potential root cause of this complaint can be attributed to: - a solution quality related issue.This is very unlikely since a sterile filtration is performed during compounding and a 100% visual inspection process of all filled syringes is performed to remove syringes with foreign material.In addition filling occurs in a grade a/b environment.- a component related issue.This is unlikely as only components are used from batches for which the specifications were checked.- cannula (needle) issue: no conclusion can be made as this is outside of the viscoelastic manufacturer¿s control.- a root cause outside the control of the manufacturing site could not be eliminated.Since the returned syringe was completely used, all batches are released according to the required specifications, the sample during final inspection was conform and no manufacturing related deviations are identified, a conclusive root cause cannot be determined.This is an isolated incident for this batch.The manufacturer internal reference number is: (b)(4).

• Brand Name: VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE
• 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: 11903548
• Report Number: 3002037047-2021-00026
• Device Sequence Number: 4420987
• Product Code: LZP
• UDI-Device Identifier: 00380651831506
• UDI-Public: 00380651831506
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: P840064
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 8065183150
• Device Lot Number: 20D21M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Initial Date Received by Manufacturer: 05/06/2021
• Supplement Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 05/28/2021
• Supplement Report FDA Received Date: 08/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DUOVISC VISCOELASTIC SYSTEM
• Outcome Attributed to Adverse Event: Required Intervention