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

Model Number	DIU150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Disturbances (2140); Discomfort (2330)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the intraocular lens (iol) will be explanted and replaced with another johnson & johnson iol (different model dib).The reason for the explant is that while the data suggested a toric was needed, a standard monofocal is a better fit.Through follow-up with the sales rep, it was learned that there was no fault of the doctor or the lens, it was just a calculation issue in that the measurements were only of the front of the cornea, but the back of the cornea was already correcting the vision, so it resulted in the wrong lens being chosen.The sales rep does not know if the explant has occurred yet.Through follow-up with the location contact, it was learned that iol was explanted.The reason for explant was because the patient experienced an unspecified visual disturbance.The patient was not happy with the vision in the right eye and wanted the lens to be explanted for a non-toric lens.It is unknown why the toric lens was originally chosen for this patient, but it was reported that the patient did not need the toric lens.No medical or surgical intervention was required and there was no patient injury.The patient is doing well post-operatively.The device was discarded.No further information was provided.
Additional Manufacturer Narrative
Date of event: unknown; requested but not provided.The best estimate date is between (b)(6) 2022 and (b)(6) 2022.Device evaluated by mfr: the device was not returned for evaluation as it was discarded; 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.An attempt was made to obtain missing information; however, the account did not have the information.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: 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: 15325455
• Report Number: 3012236936-2022-02283
• Device Sequence Number: 6484841
• Product Code: MJP
• UDI-Device Identifier: 05050474746558
• UDI-Public: (01)05050474746558(17)250323
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/23/2025
• Device Model Number: DIU150
• Device Catalogue Number: DIU150U205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2022
• Initial Report FDA Received Date: 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male