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

Model Number	DFR00V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140); Halo (2227)
Date of Event	08/23/2022
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.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the patient was experiencing blurry vision and intolerable halos and glare in their right eye (od) resulting in the need to explant the intraocular lens (iol).Distance vision was 20/40 and the patients near was j7.Through follow-up, it was learned that patient could not tolerate the lens was vision is worse.Distance vision is very blurry.The patient's pre-operative (op) uncorrected visual acuity (ucva) was 20/40 distance and best corrected visual acuity (bcva) was j5 near 20/25 distance.Post-operative on (b)(6) 2022 ucva was 20/40-1 distance and j3- near and bcva was 20/40+1 -distance and j2-near.On (b)(6) 2022 ucva was 20/40 distance and j10 near and bcva was 20/25.A non-johnson & johnson lens was implanted as a replacement.There was no incision enlargement, vitrectomy, or sutures were required.There was no patient injury.No additional information was provided.
Additional Manufacturer Narrative
Section d9: device available for evaluation? yes.Section d9: returned to manufacturer on: 11/7/2022.Section h3: 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 cut.The lens was cleaned and, no issues were observed that could contribute to or cause the complaint issues.Based on the return condition of the lens, no further product evaluation could be performed.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, MULTIFOCAL INTRAOCULAR
• 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: 15687046
• Report Number: 3012236936-2022-02638
• Device Sequence Number: 6763209
• Product Code: MFK
• UDI-Device Identifier: 05050474750623
• UDI-Public: (01)05050474750623(17)241107
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 12/10/2022

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: 11/07/2024
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU175
• 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: 10/05/2022
• Supplement Date Received by Manufacturer: 11/30/2022
• Initial Report FDA Received Date: 10/27/2022
• Supplement Report FDA Received Date: 12/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2021
• 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: 74 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White