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

Lot Number 21I24D

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

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

Event Date 01/12/2023

Event Type  malfunction  

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).

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 has been requested and received stating the procedure was completed on the same day without complications.There is no plan to explant the lens.The observed threads could not be isolated and are not available for return.This report is for the ophthalmic viscosurgical device involved in this event.

Manufacturer Narrative

All batches are released according to the required specifications.Filling is performed in a grade a environment.A 100% visual inspection of all filled syringes is performed to remove syringes with foreign material.The scrap percentage is within normal ranges.After visual inspection an aql sample is performed to check whether the visual inspection is performed conform the procedure.During assembly, pouching and packaging the operators wear protective clothing and hair caps.Investigation showed that no deviations related to this complaint were reported in the batch record assembly.At each start up assembly, every 30 minutes and at the end of the work order a visual inspection of 24 consecutive syringes is performed as an in process control check.No deviations were reported.The pouching process is performed in a class d environment.A visual inspection is performed of the sealed pouches and no deviations were observed.Foreign material is not a specific parameter that is checked during this visual inspection.Investigation showed that no deviations related to this complaint were reported in the batch record pouching.At each start up pouching, every 60 minutes and at the end of the work order a visual inspection of 10 pouches (at start up) and 4 pouches (every 60 minutes/at the end) is performed as an in process control check.No deviations were reported.After the pouching process and sterilization the product is packaged on packaging line spl03.During packaging, at each start up, every 30 minutes and at the end of the work order a visual inspection is performed on 2 completely packaged folding boxes.No deviations were reported related to foreign material in the pouch.The sample checked during final inspection is conform: no deviations were reported.The provided photos show partially used syringes without tip cap.Air bubbles are visible.No foreign material is observed.Based on the provided photos the complaint cannot be confirmed.Two used ophthalmic syringes are received as complaint sample.One syringes has no remaining volume and the second syringe contains some rest product.Several air bubbles are present in this second syringe with rest product.The syringe without remaining product is a bit blurry; possibly due to dried product.The needles were not returned.There are no component deviations observed to the returned syringes.In addition the samples were microscopically inspected but no blue or white threads are seen in the samples.Based on the investigation the complaint cannot be confirmed.A visual inspection is performed on 40 reference samples and ok, no deviations observed.In addition the product of one reference was completely pushed out and visually inspected with a magnifying glass and no deviations observed.Since no manufacturing related deviations were identified and no deviations to the returned complaint samples could be observed, a conclusive root cause could not be determined.A potential root cause for foreign material could be attributed to: - a component related issue.This is unlikely as a 100% visual inspection of all filled syringes is performed to remove syringes with foreign material.- cannula : no conclusion can be made as this is outside of the manufacturing control.- a product quality issue; however this is very unlikely as no deviations were reported concerning this complaint during the filling process, filling is performed in a grade a environment as well as a 100% visual inspection is performed to remove syringes with foreign material.- 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.Although an atypical complaint trend was identified, the product and none of the complaints have been confirmed manufacturing related through manufacturing investigation or returned sample evaluation - this complaint is not explicable from a technical point of view.No further action is required.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: 16823984
• MDR Text Key: 314100831
• Report Number: 3002037047-2023-00018
• 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
• Report Date: 09/20/2023

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: 21I24D
• 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
• Date Device Manufactured: 09/24/2021
• 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