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

Model Number	DFR00V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Flashers (1864)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The exact date is unknown, the best estimate is between the implant date and explant dates, (b)(6) 2021 and (b)(6) 2022.The device has not returned for evaluation.Therefore, a visual 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 the missing information.However, the customer did not provide the information.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.
Event or Problem Description
Doctor reported that after implanting the johnson and johnson (jnj) intraocular lens (iol) into the patient¿s right eye they experienced starbursts dysphotopsia while driving.The iol was explanted in a secondary surgical procedure and replaced with a different jnj lens model dcb00 26.0 diopter.There was no vitrectomy, sutures or incision enlargement required.No further information was provided.
Additional Manufacturer Narrative
Section d9: device available for evaluation? yes section d9: date returned to manufacturer: may 2, 2022 section h3: evaluated by manufacturer: yes device evaluation: visual inspection under magnification revealed that the iol was received cut in half.The lens was cleaned and, no issues that could contribute or be attributed to visual issues were identified.Based on the return condition of the lens (cut in half), no further product evaluation could be performed.A product quality deficiency could not be determined.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: INTRAOCULAR LENS
• 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: 14118800
• Report Number: 3012236936-2022-00889
• Device Sequence Number: 19892158
• Product Code: HQL
• UDI-Device Identifier: 05050474750753
• UDI-Public: (01)05050474750753(17)240412
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2022

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: 04/12/2024
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU240
• 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: 03/30/2022
• Supplement Date Received by Manufacturer: 06/06/2022
• Initial Report FDA Received Date: 04/15/2022
• Supplement Report FDA Received Date: 06/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2021
• 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