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	Eye Injury (1845); Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the intraocular lens (iol) was explanted.No further information was provided.
Additional Manufacturer Narrative
Weight & ethnicity: unknown; requested but not provided.Date of event: unknown; requested but not provided.The best estimate date is between(b)(6) 2022.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.Multiple attempts have been made to obtain additional information regarding the event and to obtain suspect product for evaluation; however, to date, no additional information has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Through follow-up, it was learned that the reason for explant was that the patient was experiencing glare in the right eye.The date symptoms started is unknown.Another johnson and johnson iol was implanted as replacement (different model, dib00, same diopter of 19.5).No medical or surgical intervention was required and there was no patient injury.The patient is doing fine post-operatively.The device was discarded.No further information was provided.Corrected information: based on the new information received, code 1845 (unspecified injury) has been corrected to 2140 (to capture "glare").The following sections have been updated accordingly: section a4: patient weight: 135 pounds.Section h6: health effect - clinical code: 2140 visual disturbances (to capture glare) section h6: type of investigation: 4115.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: 15947239
• Report Number: 3012236936-2022-03051
• Device Sequence Number: 6561225
• Product Code: HQL
• UDI-Device Identifier: 05050474750661
• UDI-Public: (01)05050474750661(17)240907
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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): 12/28/2022

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: 09/07/2024
• 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: 11/14/2022
• Supplement Date Received by Manufacturer: 12/12/2022
• Initial Report FDA Received Date: 12/08/2022
• Supplement Report FDA Received Date: 12/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2021
• 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: 76 YR
• Patient Sex: Female
• Patient Weight: 61 KG