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 Code	Halo (2227)
Date of Event	05/12/2021
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 in a secondary surgical procedure due to patient complaint of seeing halos all the time.A replacement lens of different model dib00 (+21.5 d) was used.There were no medical/surgical interventions required and no delay was reported.Patient outcome was reported to be unknown as the patient went back to referring doctor.No further information was provided.
Additional Manufacturer Narrative
Date of event: unknown, not provided.Best estimate date is between may 11, 2020 and jul 6, 2021.Concomitant medical products: platinum inserter, lot unknown and platinum cartridge, lot unknown.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.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: additional information received indicated that the patient is white, non-hispanic and that their symptom, halo issue first noticed on (b)(6) 2021 post-op day one (1).That the intraocular lens (iol) was taken out and a monofocal iol was put in.There was no patient injury reported.The patient was happy and was not seeing any halos.The following fields were updated accordingly: section b3: date of event: (b)(6) 2021.Section a5: ethnicity: not hispanic.Section a5: race: white.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: in review, it was noted that "additional information" box of the "h2" field in the supplementtal mdr report #1 was inadvertently not checked which it should have; therefore, the information has been corrected in this supplemental mdr report.Additional information: section d9: device available for evaluation? yes.Section d9: returned to manufacturer: yes.Section d9: date returned to manufacturer: jan 31, 2022.Section h3: device evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification revealed viscoelastic residue on the optic body and haptics and that the lens was received cut in half, which is consistent with a lens that was handled during explant.Based on the return condition of the lens, no further product evaluation could be performed on the lens.The complaint issue could not be confirmed, and no product deficiency could be determined.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: 13296516
• Report Number: 3012236936-2022-00166
• Device Sequence Number: 11599664
• Product Code: POE
• UDI-Device Identifier: 05050474579156
• UDI-Public: (01)05050474579156(17)251128
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• 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,Followup
• Report Date (Section B): 03/14/2022

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: 11/28/2025
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0230
• 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: 12/23/2021
• Supplement Date Received by Manufacturer: 01/20/2022; 02/18/2022
• Initial Report FDA Received Date: 01/19/2022
• Supplement Report FDA Received Date: 02/04/2022; 03/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2020
• 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 Ethnicity: Non Hispanic
• Patient Race: White