MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS SIMPLICITY; EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS

Model Number	DXR00V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Impairment (2138); Visual Disturbances (2140); Halo (2227); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the multifocal intraocular lens (iol) was implanted into the patient right eye.The iol was explanted in a secondary surgical procedure due to complaints of negative dysphotopsia.Replaced the lens of the right eye with a non-j&j monofocal iol.Additional information received stated that patient now have fewer halos and still have inferior quadrant vision loss (od> os) and doing better.There was incision enlargement.No other patient injury and suture/vitrectomy were not required.No further information is available.
Additional Manufacturer Narrative
Section a5: unknown, asked but not available.Section b3: date of event: unknown, not provided, but the best estimate date is between (b)(6)2022 and (b)(6)2023.Section h3-other (81): 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 and complaint history for production order 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.
Additional Manufacturer Narrative
Additional information: an additional follow-up response revealed that halos were present after implantation of original lens and the patient still has it now after exchange with non-j&j lenses.Before explant, visual acuity was udva 20/40, and now it is 20/30 with non-j&j lenses.The surgeon believes she has had a significant workup.It was not iol that caused the issue.It is likely due to cns dysfunction.No further information is available.The following sections have been updated accordingly: section b3: date of event: (b)(6) 2023.Section e1: telephone number : (b)(6).Section h3: product evaluation was not performed because the product has not been returned.If product is received after initial closure, the pi and cp (if necessary) may be re-opened to complete the return investigation.The complaint issue reported could not be confirmed.As per complaint investigation results, the product was released within specifications.The complaint issue reported could not be confirmed and no product deficiency or product malfunction could be identified.Section h6: based on the additional information received, the code from the initial mdr, clinical code: 4581 - hs-incision enlarged is no longer applicable.Health effect - clinical code: 2138 -visual impairment has been added to reflect the new information.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS SIMPLICITY
• Common Device Name: EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS
• 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 ; 7014710796
• MDR Report Key: 17628618
• Report Number: 3012236936-2023-02147
• Device Sequence Number: 20658396
• Product Code: POE
• UDI-Device Identifier: 05050474761643
• UDI-Public: (01)05050474761643(17)250407
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2023

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: 04/07/2025
• Device Model Number: DXR00V
• Device Catalogue Number: DXR00VU125
• 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: 08/03/2023
• Supplement Date Received by Manufacturer: 08/24/2023
• Initial Report FDA Received Date: 08/25/2023
• Supplement Report FDA Received Date: 09/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2022
• 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: 48 YR
• Patient Sex: Female
• Patient Weight: 66 KG