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

Model Number DIU225

Device Problem Inaccurate Delivery (2339)

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

Event Date 06/15/2022

Event Type  malfunction  

Manufacturer Narrative

Patient information: unknown/ asked but not available.If explanted, give date: not applicable, as the lens remains implanted in the eye.The device was not returned 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.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the intraocular lens (iol) was difficult to deploy and the haptic was stuck.The lens was pushed through into the operative eye, but had to be rotated into place.No other intervention was required and the lens remains implanted.The patient was doing fine post-operation.No other information was provided.

• 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: 14988414
• MDR Text Key: 304197278
• Report Number: 3012236936-2022-01806
• Device Sequence Number: 1
• Product Code: MJP
• UDI-Device Identifier: 05050474747067
• UDI-Public: (01)05050474747067(17)240131
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: DIU225
• Device Catalogue Number: DIU225U165
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/15/2022
• Initial Date FDA Received: 07/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2021
• 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