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

Catalog Number 960569J--001/0

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/15/2020

Event Type  malfunction  

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 second of two reports for this reported event.(b)(4).

Event Description

A physician reported that a viscoelastic solution was used during a cataract surgery when an elongated transparent foreign material was detected behind the intraocular lens that was left intact inside of the eye due to the patient's weak zinn's zonule and poor mydriasis.There was no report of any patient harm.

Manufacturer Narrative

Additional information is provided in sections d.4, h.4, h.6 and h.10.There was no product returned for evaluation.The complaint condition could not be confirmed.Complaint trending was reviewed for the lot code provided and one similar complaint was 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.A potential root cause of this complaint can be attributed to: - a solution quality related issue: however, a 100% visual inspection process of all filled syringes is performed to remove syringes with foreign material.The syringes are filled in a sterile environment.- the assembly process: no deviations were reported during assembly related to the complaint.In addition, the assembly is performed in a cleanroom and during assembly, the operators wear protective clothing and hair caps.- a supplier component related issue (cannula).- customer handling could also not be eliminated as potential root cause for the reported condition.As no sample was returned and no manufacturing related issues were identified, a conclusive root cause could not be determined.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: 2020-62248.

• Brand Name: PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• 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 Key: 10842349
• MDR Text Key: 217954576
• Report Number: 3002037047-2020-00025
• Device Sequence Number: 1
• Product Code: LZP
• Combination Product (y/n): N
• PMA/PMN Number: P890047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 960569J--001/0
• Device Lot Number: 20B25GA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1