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 Known Impact Or Consequence To Patient (2692)

Event Date 03/26/2019

Event Type  malfunction  

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.Additional information has been requested.(b)(4).

Event Description

A physician reported that a viscoelastic product was injected into an eye during surgery which exhibited white particles of foreign matter.After irrigation and aspiration, some of the white particles were retained inside of the eye.There was no patient harm reported.Additional information received clarified that the procedure performed was a continuous curvilinear capsulorhexis (ccc).As there was no harm to the patient after some particles were retained inside of the eye, there is no further treatment required or scheduled.

Manufacturer Narrative

A sample was received by the manufacturer.The sample was evaluated and it was found that the described complaint was not present in the sample.However, there were brown particles found that could not be identified by the chemical lab or particle lab.All testing results met specifications for this lot code at the time of release.No deviations were identified during the manufacturing of the batch that would have contributed to this complaint.No additional complaints have been received for this lot code/complaint type.Retain samples were examined at the manufacturing facility and no defects were identified.A root cause for the reported white particulate cannot be confirmed, but maybe due to silicone accumulation during plunger advancement.No action is warranted.The manufacturer internal reference number is: (b)(4).

• 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: 8492107
• MDR Text Key: 141333971
• Report Number: 3002037047-2019-00004
• 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: 02/21/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 960569J--001/0
• Device Lot Number: 18J18F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Initial Date Manufacturer Received: 03/26/2019
• Initial Date FDA Received: 04/08/2019
• Supplement Dates Manufacturer Received: 02/10/2020
• Supplement Dates FDA Received: 02/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR