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

Model Number	DFW150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Disturbances (2140); Halo (2227)
Date of Event	01/27/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol) was explanted from the patient's right eye due to the patient was experiencing unbearable glare and halo 6 weeks post-operative (op and especially at night.The incision was enlarged.It was also reported that the patient was having difficulty driving at night.Pre-operative visual acuity is 20/60 dv cc (dv-distance vision, cc-with correction).The explanted iol was replaced with another j&j lens model zcu150 18.5 diopter (different model, same diopter).Post-operative visual acuity is 20/25 -1 dv and 2025 nv sc (nv-near vision, sc-without correction).Reportedly, there was no vitrectomy and no sutures were required.No further information was provided.
Additional Manufacturer Narrative
Additional info: section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: mar 25, 2022.Section h3: evaluated by manufacturer: yes.Device evaluation: the suspect iol was received inside a specimen cup.The lens was removed and visual inspection revealed cosmetic issues and lens damage.No defects that could contribute to visual issues were observed.A product quality deficiency could not be determined.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & 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: 13773598
• Report Number: 3012236936-2022-00588
• Device Sequence Number: 19240685
• Product Code: MFK
• UDI-Device Identifier: 05050474751231
• UDI-Public: (01)05050474751231(17)240607
• 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): 05/04/2022

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: 06/07/2024
• Device Model Number: DFW150
• Device Catalogue Number: DFW150U185
• 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: 03/02/2022
• Supplement Date Received by Manufacturer: 04/29/2022
• Initial Report FDA Received Date: 03/15/2022
• Supplement Report FDA Received Date: 05/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2021
• 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 Sex: Male
• Patient Race: White