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	10/20/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an intraocular lens (iol) was explanted due to halo and glare.That at 1-month post-op examination, the patient ended up both eyes (ou) 20/20 j1, but could not tolerate halo/glare.The lens was removed and replaced with a non-johnson and johnson monofocal iol.The lens was discarded, and no further information was provided.
Additional Manufacturer Narrative
Date of event is unknown.The best estimate time would be (b)(6) 2021, as the surgeon indicated 1 month post-op examination when patient complained of having visual symptoms.Device evaluation: the product testing could not be performed as the product was not returned (the lens was discarded).The reported complaint cannot be confirmed.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.Historical data analysis: a search of complaints revealed no other complaints have been received for this production order number.Conclusion: as a result of the investigation, there is no indication of a quality product 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 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: 13503585
• Report Number: 3012236936-2022-00341
• Device Sequence Number: 3743674
• Product Code: HQL
• UDI-Device Identifier: 05050474750784
• UDI-Public: (01)05050474750784(17)240527
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/09/2022

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: 05/27/2024
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU255
• 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: 01/21/2022
• Initial Report FDA Received Date: 02/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2021
• 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