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

Model Number DCB00

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 09/19/2022

Event Type  malfunction  

Manufacturer Narrative

There was no patient contact with the product.If implanted, give date: not applicable, as there was no patient contact with the product.If explanted, give date: not applicable, as there was no patient contact with the product.Phone 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 intraocular lens (iol) packaging was not sealed.There was no patient contact with the product.The account is returning the product for evaluation.No further information was provided.

Manufacturer Narrative

Additional information: section d9: device available for evaluation: yes, returned to manufacturer on: oct 31, 2022 section h3: device evaluated by manufacturer: yes device evaluation: the product was returned to the manufacturing site for evaluation.-the complaint sterilization pouch was received with original handpiece inside of the handpiece tray.The original folding carton, patient stickers, a blank notification card, and the directions for use (dfu) was received as well.-visual inspection of the sterilization pouch revealed that manufacturer side of the pouch was not sealed and that the heat seal was not present.No further issues with the pouch were observed.-the complaint issue "sterility assurance concerns" was identified during product evaluation; however, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.Therefore, there is no indication of a product deficiency or product malfunction.Manufacturing record review: -the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.No non conformance report (ncr) were found during record review.A search of complaints related to this production order (po) was performed.The search revealed no additional complaint folders for this po number.Product deficiency not identified.Conclusion: based on the complaint investigation and product evaluation results further investigation is required.A failure investigation (fi) is being performed to further investigate this complaint issue.The complaint issue reported was verified.Based on the analysis of the returned device, there is no indication of product quality deficiency.

Manufacturer Narrative

A failure investigation was completed and the investigation findings concluded that the device did not meet specifications and the failure was attributed to operator error.Therefore, the complaint issue reported is confirmed as manufacturing related.A corrective and preventive action (capa) was previously open for this issue.The product involved in this event was manufactured prior to the implementation of the capa.A review of bounding confirmed that there were no additional units affected for similar issues.Awareness communication was provided to all first pack and boxing personnel.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: 15592486
• MDR Text Key: 306879609
• Report Number: 3012236936-2022-02600
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474636187
• UDI-Public: (01)05050474636187(17)230122
• 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: Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/22/2023
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2020
• 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