MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS SIMPLICITY; INTRAOCULAR LENS

Model Number DIB00

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

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

Event Date 08/16/2023

Event Type  malfunction  

Manufacturer Narrative

Section a2, a4 and a5: per regulation eu 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Section d6a: if implanted, give date: not applicable, as there was no patient contact with the product.Section d6b: if explanted, give date: not applicable, as there was no patient contact with the product.Section e1 - telephone number: (b)(6).Section h3 - other (81): the intraocular lens (iol) was not returned for evaluation.Therefore, a failure analysis of the complaint device could not 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 and possible product return and evaluation, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that when opening the pouch of the preloaded intraocular lens (iol), the nurse noticed it to be very lightly closed.Account described it as feeling like the plastic inside the pouch was poorly attached to the paper of the pouch.The nurse raised the question if the sterility of the package could be compromised.Therefore, they decided not to use this lens.Another lens was implanted and no adverse affect on the patient was reported.Through follow-up we learned that the issue according to the customer was not due to transport or use error.The outer box had no damages.Account indicated that the nurse who opened the package is very experienced and knows how proper opening of a sterile pouch is performed.While opening the pouch it felt it was almost not closed.It was more like ¿too easy to open¿, it was easily detectable.No further information was provided.

Manufacturer Narrative

Additional information: section d9 - device available for evaluation? yes.Section d9 - date returned to manufacturer: 28-sep-2023.Section h3 - device evaluated by manufacturer? yes.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection of the pouch found that it was received opened and no damage to the carton was identified.Visual inspection under magnification revealed that the complaint handpiece was received with the plunger rod advancing the lens to the body of the cartridge.The lens module was inspected and, no marks that would indicate that the plunger rod advanced incorrectly.The handpiece was disassembled and the assembly was inspected, no issues that could cause or contribute to the complaint issue could be identified.Visual inspection under magnification revealed that the complaint cartridge was received with the cartridge neck damaged and with the cartridge tip completely removed (missing).Further inspection of the cartridge revealed that there was an appropriate amount of ophthalmic viscosurgical device (ovd)/balanced saline solution (bss) used.The complaint issues of packaging issues and sterility assurance concerns were not identified during product evaluation.The other observed issues during the product evaluation could not be confirmed to be related to the manufacturing or design process.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS SIMPLICITY
• Type of Device: INTRAOCULAR LENS
• 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: 17716404
• MDR Text Key: 323051209
• Report Number: 3012236936-2023-02163
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474655522
• UDI-Public: (01)05050474655522(17)250825
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIB00
• Device Catalogue Number: DIB00I0260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2022
• 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