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 Codes	Blurred Vision (2137); Visual Impairment (2138)
Date of Event	12/09/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an intraocular lens (iol) did not give enough near vision without glasses despite target -1-25.Problem occurred at all times post-implant.Visual acuity (va) pre-operative (op): 20/20 glare to 20/40, post-op va: 20/20.The patient needed lens exchange to a multifocal lens.There was incision enlargement, but no vitrectomy, no sutures.Standard post-op meds were given.Reportedly, the patient had cataract surgery on the right eye (od).The doctor did the surgery with an eyhance toric.At patient's 1 week appointment, it is noted ¿patient not happy with her vision.She says her vision is very blurry distance and near od.Os (left eye) is still blurry.Patient wants to wait until od is better before proceeding with os surgery.¿ patient has had numerous visits and has not been happy with her vision.The patient came back and saw the doctor and they discussed doing an iol exchange.Explant was replaced with a non-johnson and johnson iol.The product is not available for return.No other information was provided.
Additional Manufacturer Narrative
(ethnicity): unknown/ not provided.Asku.Device evaluation: the device was not returned at the manufacturing site as it was discarded; therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.A search of complaints related to this production order (po) was performed.The search of complaints revealed that no similar complaint for this production order number has been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be confirmed.An attempt has been made to obtain missing information; however, no definitive response has been received.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: 16530288
• Report Number: 3012236936-2023-00533
• Device Sequence Number: 2621589
• Product Code: MJP
• UDI-Device Identifier: 05050474747173
• UDI-Public: (01)05050474747173(17)240123
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/13/2023

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: 01/23/2024
• Device Model Number: DIU225
• Device Catalogue Number: DIU225U220
• 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: 02/20/2023
• Initial Report FDA Received Date: 03/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2021
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 85 KG
• Patient Race: White