MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number DIU150

Device Problems Delivered as Unsterile Product (1421); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 04/22/2022

Event Type  malfunction  

Manufacturer Narrative

Age or dob, weight, ethnicity: not applicable, as there was no patient contact with the product.Implant date: if implanted, give date: not applicable, no patient contact with the product.Explant date: if explanted, give date: not applicable, no patient contact with the product.Initla reporter name and address: telephone number: (b)(6).The device was not returned for evaluation.Therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the preloaded device popped out when the package was opened and dropped to the floor.Account indicated that the packaging was not sealed properly and effectively enough that it opened far too easily, causing the injector to pop too quickly.As the seal was not strong enough to hold the package together, there was a concern with the sterility of the device.No further information was provided.

Manufacturer Narrative

Additional information: section d10: device available for evaluation ¿ yes, returned to manufacturer on 6/2/2022.Section h3: device returned to manufacturer ¿ yes.Device evaluation: product evaluation was performed under magnification.The complaint device presented with a lens advanced into the cartridge and viscoelastic in the cartridge.The sterilization pouch was inspected and no issues were identified.The complaint issue were not confirmed.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.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.

• Brand Name: TECNIS IOL
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 14438630
• MDR Text Key: 292184577
• Report Number: 3012236936-2022-01306
• Device Sequence Number: 1
• Product Code: MJP
• UDI-Device Identifier: 05050474726420
• UDI-Public: (01)05050474726420(17)240912
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/17/2022

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 Model Number: DIU150
• Device Catalogue Number: DIU150I200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/22/2022
• Initial Date FDA Received: 05/19/2022
• Supplement Dates Manufacturer Received: 07/26/2022
• Supplement Dates FDA Received: 08/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1