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

Model Number	DIU150
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	04/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient required an explant due to the intra-ocular lens (iol) in the right eye rotating 40 degrees and the power being off.A replacement lens of the same mode, but different diopter (14.0) was used.There was no reported patient injury.The paient is doing good post-op.No additional information provided.
Additional Manufacturer Narrative
Ethnicity: unknown; requested but not provided.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.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation? yes returned to manufacturer on: 10/20/2022.Device evaluated by manufacturer¿ yes.Device evaluation: the complaint lens was received inside of a specimen cup.Visual inspection under magnification revealed that the complaint lens was received coated in viscoelastic residue.The lens was cleaned and, no issues that could contribute to or cause the complaint issues could be identified.The complaint issues of ¿unexpected postop refraction¿ and "rotation" was not confirmed.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, and the reported issue could not be confirmed.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: 14725814
• Report Number: 3012236936-2022-01433
• Device Sequence Number: 2213727
• Product Code: MJP
• UDI-Device Identifier: 05050474746404
• UDI-Public: (01)05050474746404(17)240824
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/24/2024
• Device Model Number: DIU150
• Device Catalogue Number: DIU150U130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/31/2022
• Supplement Date Received by Manufacturer: 11/02/2022
• Initial Report FDA Received Date: 06/17/2022
• Supplement Report FDA Received Date: 11/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PLATINUM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Race: White