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 Code	Visual Impairment (2138)
Date of Event	11/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The exact date is unknown, the best estimate is after the implant date (b)(6) 2021 and prior to the explant date (b)(6) 2022.The device has not returned for evaluation.Therefore, a visual 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 the missing information.However, to date it has not been received.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.
Event or Problem Description
It was reported that after implanting an intraocular lens (iol) into the patient¿s left eye, their distance vision was not optimized, not sharp.The left was monovision for distance, had residual hyperopia and astigmatism.Reportedly, in november, the patient¿s vision was not optimal.The iol was explanted (b)(6) 2022.There was no incision enlargement, sutures, or vitrectomy required.Pre-operative visual acuity 20/40 and post operative visual acuity is 20/25- 20/30.The iol exchange was successful as the final outcome improved following the iol explant.On (b)(6) 2022, the patient¿s visual acuity was 20/25 sc (without correction) and best corrected 20/20-.No other information was provided.
Additional Manufacturer Narrative
Additional information: additional information received indicated that the patient was white/american with weight of 155 pounds.The date of first symptoms was noted to be (b)(6) 2021.It was also indicated that the replacement intraocular lens (iol) was a 17.5 diopter iol of the same model.The following fields were updated accordingly: section a4: patient weight: 155 pounds.Section a5: race: white/american.Section b3: date of event: (b)(6), 2021.Corrected data: upon further review, it was noticed that since the original lens was 16.5 diopters and the replacement lens was 17.5 diopter, there is a significant change of 1.0 diopter which indicates that the patient would have needed a different lens power to be calculated/used.As the reported event was not due to the lens product problem or malfunction.Therefore, the event is no longer reportable and no further information will be provided under this manufacturer report number 3012236936-2022-00610.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: 13727394
• Report Number: 3012236936-2022-00610
• Device Sequence Number: 20035329
• Product Code: MJP
• UDI-Device Identifier: 05050474746473
• UDI-Public: (01)05050474746473(17)240113
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 03/28/2022

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: 01/13/2024
• Device Model Number: DIU150
• Device Catalogue Number: DIU150U165
• 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: 03/02/2022
• Supplement Date Received by Manufacturer: 03/11/2022
• Initial Report FDA Received Date: 03/10/2022
• Supplement Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2021
• 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 Sex: Male
• Patient Weight: 70 KG
• Patient Race: White