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)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was 20/20 j1 but never adjusted to glare and halos after the implantation of the synergy intraocular lenses (iol) in both eyes.There was no refractive error, or residual astigmatism.The lenses were exchanged to non-johnson and johnson monofocal lenses.No complications were observed during the exchange procedures described as being routine surgeries.Patient outcome was reported as having no complications.No further information was provided.It was unknown from which eyes the lenses were explanted.This report represents the right (od) and a separate report will be submitted for the left (os) eye.
Additional Manufacturer Narrative
Age, weight and ethnicity ¿ unknown, not provided.Date of event is unknown.The best estimate date would be between the date the lens was implanted, (b)(6) 2021, and the date it was reported on january 25, 2022.If explanted; give date: unknown, not provided.Initial reporter email address: unknown, not provided.Attempts have been made to obtain missing information; however, to date, no response has been received.Device evaluation: since product was not returned, the complaint issue reported could not be verified.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: 13529078
• Report Number: 3012236936-2022-00361
• Device Sequence Number: 17153701
• Product Code: HQL
• UDI-Device Identifier: 05050474750708
• UDI-Public: (01)05050474750708(17)240331
• 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): 02/14/2022

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: 03/31/2024
• 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: 01/25/2022
• Initial Report FDA Received Date: 02/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2021
• 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: Male