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

Model Number ZCB00

Device Problems Labelling, Instructions for Use or Training Problem (1318); Delivered as Unsterile Product (1421); Component Missing (2306)

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

Event Type  malfunction  

Event Description

It was reported that the intraocular lens (iol) box was received sealed, with the first plastic layer (outer most) sealed.Upon opening, the inner plastic layer that covers the lens was not sealed.There was no lens inside the lens holder, and no lens sticker and lens code.No further information available.

Manufacturer Narrative

Section a2, a4 and a5: unknown/ not provided.Patient information cannot be provided due to personal data privacy legislation/policy.Section b3: date of event: unknown, not provided.Section d6a: implant date: not applicable, as lens was not implanted.Section d6b: explant date: not applicable, as lens was not explanted.Section e1: initial reporter first name: information unknown/not provided.Section e1: initial reporter telephone number: (b)(6).Section h3-other (81): it was indicated that the device is not returning 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

Section d9: device available for evaluation: yes.Date returned to manufacturer: 31 aug 2023.Section h3: device evaluated by manufacturer: yes.Device evaluation: the complaint lens case and sterilization pouch were received inside of the original folding carton with patient stickers, a blank patient id and implant notification card, and the directions for use (dfu).No lens was received as part of this return.Visual inspection of the lens case revealed that the lens insert clicked when centered over the daisy wheel.Resistance could be felt when the lens insert was moved from the center of the daisy wheel.The seals on both sterilization pouches were inspected and no issues could be identified.The complaint issue were not identified during product evaluation.Therefore, there is no indication of a product deficiency or product malfunction.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• 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: 17419012
• MDR Text Key: 320082400
• Report Number: 3012236936-2023-01838
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474531710
• UDI-Public: (01)05050474531710(17)261231
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/30/2022
• 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