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

Model Number	DFR00V
Medical Device Problem Codes	Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Eye Injury (1845); Blurred Vision (2137)
Date of Event	11/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an intraocular lens (iol) was explanted from a patient's left eye in a secondary surgical procedure due to mechanical failure.There was an incision enlargement, and the lens was removed in whole, but no vitrectomy or sutures were required.There was no patient injury reported.No further information was received.
Additional Manufacturer Narrative
Date of event: unknown, not provided, but the best estimate date is between jul 26, 2022 and nov 2, 2022.The intraocular lens (iol) was not returned for analysis.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.An attempt has been made to obtain additional information regarding the event; 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 from customer clarified that " mechanical failure" was that the patient reported constant hazy vision affecting all activities especially when driving.That the patient's visual issues first occurred or was diagnosed on (b)(6) 2022.Another johnson & johnson lens of different model (aab00), but the same diopter (+18.50) was used as the replacement.The patient was reported to be stable.The following field was updated accordingly: section b3: date of event: 11/1/2022.Section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: dec 19, 2022.Section h3: device evaluated by manufacturer: yes.Device evaluation: the suspect lens was received stuck to medical gauze.No additional product or components were received.Visual inspection under magnification revealed that the lens was received coated in viscoelastic residue.The lens was cleaned and inspected and damage to the haptics was identified.The complaint issues were not confirmed.The other observed issue found during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Therefore, there is no indication of a product deficiency or product malfunction.Corrected data: based on the additional information received from the customer, only the "adverse event" would be selected for the section "b1 - report type" as the event is only considered to be an adverse event¿ and is no longer a "product problem".In review, it was also noted that the "g4 -combination product" field was inadvertently not populated in the initial mdr report, which has been corrected in this follow up report.Additionally, it was noticed that health effect - clinical code (1845) and medical device problem code (1384) were entered in section "h6" of the initial mdr report which based on the additional information received, these codes would need to be corrected in this supplemental mdr report.Therefore, the following fields were updated accordingly: section b1: report type: adverse event.Section g4: no.Section h6: health effect - clinical code: 2137 - blurry vision: visual impairment.Section h6: medical device problem code:2993 - no reported device problem.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: 15883019
• Report Number: 3012236936-2022-02960
• Device Sequence Number: 20101651
• Product Code: MFK
• UDI-Device Identifier: 05050474750647
• UDI-Public: (01)05050474750647(17)240814
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/14/2024
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU185
• 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: 11/03/2022
• Supplement Date Received by Manufacturer: 01/13/2023
• Initial Report FDA Received Date: 11/29/2022
• Supplement Report FDA Received Date: 02/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: VISCOELASTIC, AMVISC.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male