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

Model Number DIU150

Device Problems Misassembled (1398); Inaccurate Delivery (2339)

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

Event Date 02/07/2022

Event Type  malfunction  

Event Description

It was reported that the preloaded intraocular device injected the intraocular lens (iol) backwards and the surgeon quickly turned to the correct direction.The lens remains implanted in patient's operative eye.There was no patient injury reported.No further information was provided.

Manufacturer Narrative

Age or date of birth, weight and ethnicity: unknown as information was asked but it was not provided.If explanted, give date: not applicable, as lens remains implanted.The lens is not returning for evaluation as it remains implanted.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

Correction: upon further review, it was identified that the date in section g3 of the originally submitted report was incorrectly populated as feb 14, 2022 and the correct date should have been feb 10, 2022.Also, section h6: medical device problem code: 1398 - misassembled code was incorrectly chosen in the initial report submitted (mfr 3012236936-2022-00568).Therefore, it is being removed as it does not apply.Hence, this correction report is being submitted to capture these errors.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Section d9: device available for evaluation: yes section d9: returned to manufacturer on: feb 28, 2022 section h3: device evaluated by manufacturer: yes device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection under magnification revealed that the handpiece was received with the plunger rod fully advanced.Minor plunger rod damage was identified.The handpiece was disassembled and the assembly was inspected, no assembly issues were identified.No lens was received as part of this return, therefore no product evaluation could be performed on the lens.Based on the return condition of the product (no lens or photo/video) the complaint issue delivery issue could not be confirmed.The complaint issue assembly issue could not be confirmed.Therefore, no product deficiency could be identified.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: 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: 13676959
• MDR Text Key: 286649277
• Report Number: 3012236936-2022-00568
• Device Sequence Number: 1
• Product Code: MJP
• UDI-Device Identifier: 05050474746558
• UDI-Public: (01)05050474746558(17)241106
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2022
• 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: DIU150U205
• 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: 04/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2021
• 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