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); Halo (2227)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown; the best estimate date is between on (b)(6) 2021 and on (b)(6) 2023.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 were made to obtain the missing information and product availability for return; however, no additional information has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the intraocular lens (iol) will be explanted in two to four weeks.Through follow-up, it was learned that the lens was explanted from the right eye on (b)(6) 2023 due to blurry vision and halos at night (despite spectacle correction).The issue started immediately after surgery, but it was hoped that the patient would neuro-adapt.The patient had stopped driving at night due to the visual issues.The patient's pre-operative visual acuity (va) was 20/50.The va after initial implant was 20/20-1 (very blurry and hazy).No further information was provided.
Additional Manufacturer Narrative
Additional information was received reporting that a non-johnson and johnson intraocular lens (iol) was implanted as replacement.There was no patient injury and no medical or surgical intervention was required.The patient is doing fine post-operatively with best correct visual acuity 20/25 with some dry eye symptoms.No further information was provided.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: 16561296
• Report Number: 3012236936-2023-00676
• Device Sequence Number: 5691395
• Product Code: MFK
• UDI-Device Identifier: 05050474750661
• UDI-Public: (01)05050474750661(17)240611
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 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): 04/17/2023

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: 06/11/2024
• 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: 02/22/2023
• Supplement Date Received by Manufacturer: 03/24/2023
• Initial Report FDA Received Date: 03/16/2023
• Supplement Report FDA Received Date: 04/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2021
• 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 Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian