MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS IOL; LENS, MULTIFOCAL INTRAOCULAR

Model Number	DFR00V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	10/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for evaluation as it was discarded.A record review was performed and no product deficiency identified as all units were released within specification.Based on the information obtained, product malfunction and product deficiency cannot be confirmed.No further investigation is required.Johnson & johnson surgical vision will continue to monitor this type of complaints.Attempts have been made to obtain the missing information.However, to date it has not been received.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.
Event or Problem Description
It was reported that after implanting the jnj iol, the patient experienced blurry vision.The issue was reported one day post-op.The iol was explanted and replaced with a different multifocal lens.The patient is doing well post-op.They have fully recovered.No further information was provided.
Additional Manufacturer Narrative
Corrected data.This is to correct the initial submission section e1, email address.Section h6 type of investigation and investigation findings.Section e1, email address: stated barsamvisioncare.Com but should have been (b)(6).Section h6, type of investigation should have reported 4109-historical data analysis.Section h6, investigation findings stated 3221-no findings available but should have been 213-no device problem found.Section h10 should have also included the following.Device evaluation: the product was not returned for evaluation as it was discarded.A record review was performed and no product deficiency identified as all units were released within specification.Based on the information obtained, product malfunction and product deficiency cannot be confirmed.No further investigation is required.Johnson & johnson surgical vision will continue to monitor this type of complaints.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no other complaints were received for this production order.Conclusion: based on the investigation, no product deficiency was identified.

• Brand Name: TECNIS IOL
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• Manufacturer (Section D): AMO MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 15897420
• Report Number: 3012236936-2022-02852
• Device Sequence Number: 5390465
• Product Code: MFK
• UDI-Device Identifier: 05050474750708
• UDI-Public: (01)05050474750708(17)240615
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2023

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: 06/15/2024
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU215
• 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: 11/07/2022
• Supplement Date Received by Manufacturer: 01/23/2023
• Initial Report FDA Received Date: 12/01/2022
• Supplement Report FDA Received Date: 02/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2021
• 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: 67 YR
• Patient Sex: Female