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

Model Number	DFR00V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140)
Date of Event	11/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated by mfr: 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.An attempt was made to obtain missing information; however, the account did not have the information.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol) was explanted from the patient's left eye as the patient was not happy with the multifocal implant.The patient was not able to read and has tried for almost a year.The patient complained of poor vision, dysphotopsia, and not tolerating the lens.There was no vitrectomy, incision enlargement, or sutures reported.There was no patient injury.A non-johnson & johnson light adjustable lens was implanted as a replacement.The patient has recovered.It was noted that the device will not be returned as it was discarded.No other information was provided.
Additional Manufacturer Narrative
Corrected data: in review, it was also noted that instead of code 4115, an incorrect code (4114) was inadvertently entered in the section h6 (type of investigation) of the initial mdr report and the "h3-81 (other)" justification in the "h10" should have indicated that the lens was discarded which it did not; therefore, the information has been corrected in this supplemental mdr report as indicated below: section h6: type of investigation: 4115 section h3-other (81): the intraocular lens (iol) is not returning for evaluation as it was discarded; 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.All pertinent information available to johnson and 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: 15993072
• Report Number: 3012236936-2022-03123
• Device Sequence Number: 6209020
• Product Code: MFK
• UDI-Device Identifier: 05050474750661
• UDI-Public: (01)05050474750661(17)240810
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2022

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: 08/10/2024
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU195
• 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: 12/15/2022
• Supplement Date Received by Manufacturer: 12/15/2022
• Initial Report FDA Received Date: 12/15/2022
• Supplement Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2021
• 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: 79 YR
• Patient Sex: Female