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

Model Number	ZXR00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Disturbances (2140); Halo (2227)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an intraocular lens (iol) was explanted from a patient¿s right eye due to halos and unacceptable vision.That despite very good surgical outcome, visual acuity, good uncorrected visual acuity (ucva) distance & near and giving adaptation time, the patient was not able to tolerate glare/halos especially during night, sees artifacts both day & night and insisted on iol exchange.Best spectacle corrected visual acuity (bscva) pre-op: 20/20 - post-op: 20/20.A replacement lens of different model and diopter (dib00 +21.5 d) was used.Unplanned sutures were used, but no incision enlargement and no vitrectomy were required.It was indicated that there were no complications and that the patient is doing well.On (b)(6) 2023, without correction (sc): 20/60, pinhole (ph): 20/40, best corrected visual acuity (bcva): 20/20.Within two weeks of iol exchange, new peripheral hemorrhage in right eye was observed through dilation likely causing visual disturbance.The patient was referred to retinal specialist for focal vitreous hemorrhage and possible small tear.No further information was provided.
Additional Manufacturer Narrative
Section b3: date of event: exact date is unknown/not provided.Best estimate event occurred 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, 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.Section h6: health effect - clinical code: 2140 (visual disturbance dysphotopsia - requiring surgical intervention: visual impairment and glare requiring surgical intervention).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.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: apr 19, 2023.Section h3: device evaluated by manufacturer: yes.Device evaluation: the complaint lens was received in an opened non-jnj tray.A foam cloth and a foam cylinder was received as well.Visual inspection under magnification revealed that the lens was received with no cosmetic defects before and after cleaning.No defects that could contribute to visual issues were observed.The complaint issues were not confirmed during product evaluation and no other issues were identified.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.Please note that the information reported in sections d2 (common device name), h.6 (health effect -clinical code and medical device problem code), section g.1 (manufacturer contact e-mail) and section h6 (investigation conclusions) is information that remains unchanged from the initial emdr report.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• 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 ; 7142478552
• MDR Report Key: 16797588
• Report Number: 3012236936-2023-01011
• Device Sequence Number: 3139480
• Product Code: POE
• UDI-Device Identifier: 05050474579118
• UDI-Public: (01)05050474579118(17)260730
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: 2023
• 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): 05/26/2023

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: 07/30/2026
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0210
• 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: 03/29/2023
• Supplement Date Received by Manufacturer: 05/05/2023
• Initial Report FDA Received Date: 04/24/2023
• Supplement Report FDA Received Date: 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2021
• 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: 69 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White