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

Lot Number 21H06B

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

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

Event Date 01/16/2023

Event Type  malfunction  

Event Description

A nurse reported that during a cataract extraction with intraocular lens (iol) implant procedure, the blue or white threads stuck to the iols.Attempts were made to polish away the thread.There was patient contact, but no patient harm occurred.Additional information was requested and received stating the procedure was able to be completed absolutely normally without complication.This report is for the ophthalmic viscosurgical device involved in this event.

Manufacturer Narrative

A sample has been received by manufacturing that has not yet been evaluated.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).

Manufacturer Narrative

No similar complaints have been received so far for this lot.No material deviations are reported for the used cannulas.All batches are released according to the required specifications.Investigation showed that no in process control deviations related to this complaint were reported during filling.Two used cellugel syringes are returned as complaint sample.Both syringes are empty, no rest product is available in the syringes.One syringe looks hazy/misty, potentially due to the dried up product.No needles were returned with the returned syringes.No component deviations are visible to the complaint syringes.According to local procedures, retain sample testing was not performed.As the samples are already used and no manufacturing related deviations were identified, a conclusive root cause could not be determined.A potential root cause of this complaint can be attributed to: - a solution quality related issue.This is very unlikely since 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 environment.- a component related issue (cannula).No conclusion can be made since no sample is returned, a root cause outside the control of the manufacturing site could not be eliminated.Review of the manufacturing documentation, lot complaint history and evaluation of samples found no issues which would have contributed to the reported complaint condition.In the absence of an atypical complaint trend and as no manufacturing related issues were identified during the investigation, this complaint is not justified from a technical point of view.No further action is required.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

• Brand Name: CELLUGEL 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
• Manufacturer (Section G): ALCON - COUVREUR N.V./ALCON - BELGIUM; rijksweg 14; puurs B-287 0; BE B-2870
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 16822404
• MDR Text Key: 314076680
• Report Number: 3002037047-2023-00014
• Device Sequence Number: 1
• Product Code: LZP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P990023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 09/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 21H06B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ACRYSOF SP NATURAL; CANNULA UNSPECIFIED; D CARTRIDGES; IOL DELIVERY SYST