MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS; TORIC IOLS

Model Number ZCW150

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 11/18/2020

Event Type  malfunction  

Manufacturer Narrative

If implanted, give date: information unknown/not provided.If explanted, give date: not applicable as the device remains implanted.(b)(6).Device evaluation: the product testing could not be performed as the product was not returned (the lens remains implanted).The reported complaint cannot be confirmed.Manufacturing record evaluation: the manufacturing records for the device were reviewed.The product was manufactured and released according to specifications.A search in complaint system revealed no other complaints have been received for this production order number.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that three intraocular lenses (iols) were found to have hard threadlike material attached to them.The lenses were in the eye when foreign materials were noted.To date, no impact to the patients have been reported.There was no patient injury reported.No further information was provided.This emdr report is for the third intraocular lens.Separate reports will be submitted for the other two lenses.

• Brand Name: TECNIS
• Type of Device: TORIC IOLS
• Manufacturer (Section D): AMO MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen 9728 NX; NL 9728 NX
• Manufacturer Contact: somyata nagpal ; van swietenlaan 5 address -; groningen 9728 -NX ; NL 9728 NX
• MDR Report Key: 11168863
• MDR Text Key: 227326927
• Report Number: 9614546-2021-07024
• Device Sequence Number: 1
• Product Code: MJP
• UDI-Device Identifier: 05050474698352
• UDI-Public: (01)05050474698352(17)250121
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZCW150
• Device Catalogue Number: ZCW150I270
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1