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

Model Number	DIU225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	07/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Attempts were made to obtain the missing information; however, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the patient had refractive surprise in their left eye (os) requiring an explant of the intraocular lens (iol).No incision enlargement, sutures, or vitrectomy was required.The patient is stated to be temporarily impaired.No further information was provided.
Additional Manufacturer Narrative
Corrected data/additional information: new information was received that the replacement lens was diu 225 19d, sn (b)(6) upon further review, this event is now determined to be not reportable.Therefore, there will no longer be any further reporting under mfr report number 3012236936-2022-02302.Additional information: section d9: device available for evaluation? yes section d9: returned to manufacturer on: 10/6/2022 section h3: device evaluated by manufacturer¿ yes.Device evaluation: the complaint lens was received inside of a specimen vial.A different serial numbers folding carton (sn:(b)(6), patient stickers, a patient id card, and the dfu were received as well.Visual inspection under magnification revealed that the complaint lens was received cut in half.The lens was cleaned and, a chip on the edge of the lens was observed however; no issues that could contribute to or cause an unexpected postoperative refraction could be identified.Based on the return condition of the lens, no further product evaluation could be identified.The complaint issue "hs-unexpected postop refraction" was not confirmed.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.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 deficiency or product malfunction.All pertinent information available to johnson and 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: 15376475
• Report Number: 3012236936-2022-02302
• Device Sequence Number: 5674234
• Product Code: MJP
• UDI-Device Identifier: 05050474747081
• UDI-Public: (01)05050474747081(17)240704
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2022

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: 07/04/2024
• Device Model Number: DIU225
• Device Catalogue Number: DIU225U175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2022
• Supplement Date Received by Manufacturer: 10/12/2022
• Initial Report FDA Received Date: 09/08/2022
• Supplement Report FDA Received Date: 10/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/04/2021
• 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 Age: 60 YR
• Patient Sex: Male