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 02/03/2023

Event Type  malfunction  

Event Description

It was reported that the preloaded intraocular lens (iol) was found to be unsterile upon opening in the operating room.The packaging was damaged and there was a slit (opening) in the clear plastic.Through follow-up, it was learned that one of the operating room nurses noticed that there was a small plastic piece of inner packaging that was detached near the cut in the inner packaging.This was noticed just before taking the device out.Only the inner plastic that covers the insertion device was damaged.No damage was noticed on the device box prior to opening it or on the shipping box.There was no use error.There was no patient contact.The procedure was completed successfully using a back-up lens (same model and diopter).No further information was provided.

Manufacturer Narrative

Not applicable, as there was no patient contact.If implanted, give date: not applicable, as there was no patient contact.If explanted, give date: not applicable, as there was no patient contact.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.

Manufacturer Narrative

The product was received for evaluation.Additional information: section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: mar 14, 2023.Section h3: evaluated by manufacturer: yes.Device evaluation: the complaint sterilization pouch was received unopened; however, a tear/hole was observed in the mylar side on the center of the sterilization pouch.No additional defects were observed.Inspection of the complaint folding carton revealed that some marks were observed in the folding carton box, none of them broke the box.There was no damage to folding carton consistent with the observed issues.The same product model and same outer pouch was used for testing.The complaint issue reported was verified since a potential cause related to manufacturing was identified.Based on the condition observed in the sample returned, the product did not meet specifications.The operators that performed visual inspection for this production order could have omitted to perform thorough visual inspection, leading to a non-conforming unit.Awareness was conducted to these areas to reinforce the correct placement of the device inside the pouch and to reinforce the visual inspection during this process, to prevent recurrence.Conclusion: based on the analysis of the returned device and the complaint history search, the complaint issue reported was considered verified and determined isolated event since no failure trend was identified.Awareness was conducted to the employees to reinforce the visual inspection during the process.These types of events will continue to be monitored.No escalation required.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

During retrospective review, it was identified that a code should be added to capture the damaged packaging.Therefore, this supplemental report is capturing this corrected information and the following field has been updated accordingly: section h6: medical device problem code 2975 - manufacturing, packaging or shipping problem.All pertinent information available to johnson & 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: 16513582
• MDR Text Key: 311110012
• Report Number: 3012236936-2023-00616
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474731752
• UDI-Public: (01)05050474731752(17)251031
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2023
• 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: DIB00U0200
• 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: 12/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2022
• 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