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

Model Number	DFW150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Halo (2227)
Date of Event	12/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The intraocular lens (iol) 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.An attempt has been made to obtain missing information; however, to date, the information has not been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol) was extracted from the patient's right eye.Mr pre-op: -10.25+0.75x135 20/20-2.Mr post-op day 6: -0.25+0.50x92 20/20.The patient complained of consistent foggy vision and circles in vision.Worse with more lighting.No surgical complications reported.No vitrectomy was required.Post op drops given.Cells and flare minimal.Iris trans illumination defects parallel.Everything else within normal.Optical coherence tomography (oct) completed and normal.No other information was provided.
Additional Manufacturer Narrative
Corrected data: upon further review it was noted that the implant date and gender in initial report were incorrect.Also, "g4" field which should have been populated with "no" was inadvertently left blank in the initial mdr report.Therefore, these information have been corrected in this supplemental mdr report and the following fields have been updated accordingly: section a3: female.Section d6a: implant date: (b)(6) 2022.Section g4: combination product: no.Additional information: additional information was provided that the patient is much happier with a monofocal lens.The patient's race, and ethnicity, date of event, and explant date, were provided.The product has been discarded.No other information was provided.Section a5:race: white and ethnicity: not hispanic section b3: date of event: dec.7, 2022.Section d6b: explant date: (b)(6) 2022.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 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: 16110069
• Report Number: 3012236936-2023-00046
• Device Sequence Number: 16652396
• Product Code: MFK
• UDI-Device Identifier: 05050474751040
• UDI-Public: (01)05050474751040(17)250126
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2023

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: 01/26/2025
• Device Model Number: DFW150
• Device Catalogue Number: DFW150U090
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2022
• Supplement Date Received by Manufacturer: 03/24/2023
• Initial Report FDA Received Date: 01/05/2023
• Supplement Report FDA Received Date: 04/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2022
• 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: 37 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White