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

Model Number	DFR00V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Disturbances (2140); Halo (2227)
Date of Event	04/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was experiencing halo and glare resulting in the need for an explant.There was no reported patient injury and the patient is reported to be doing okay.The intraocular lens (iol) will not be returned as it was discarded.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned 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.Attempts were made to obtain the missing information; however, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information was received that the patient was unable to drive at night and that this event was for the left eye (os).All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information received: received new information that suspect lens was replaced with dib00 24.5 sn (b)(6).Nothing wrong with the lens.Patient had visual discomfort, the patient wanted the lens removed.The doctor tried to explain to the patient that type 1 glare is intrinsic to the lens and most that most patients experience it, but the patient did not like it and wanted the lens removed.The doctor offered to do a laser treatment and try different drops, but the patient refused and wanted the replacement iol.Section a4 patient weight: 141 pounds section b3 date of event: (b)(6) 2022 all pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: INTRAOCULAR LENS
• 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: 14838271
• Report Number: 3012236936-2022-01643
• Device Sequence Number: 2382210
• Product Code: HQL
• UDI-Device Identifier: 05050474750753
• UDI-Public: (01)05050474750753(17)240925
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 08/22/2022

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: 09/25/2024
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU240
• 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: 06/07/2022
• Supplement Date Received by Manufacturer: 08/04/2022; 08/19/2022
• Initial Report FDA Received Date: 06/27/2022
• Supplement Report FDA Received Date: 08/12/2022; 08/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2021
• 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: 66 YR
• Patient Sex: Female
• Patient Weight: 64 KG