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	Flashers (1864); Vitreous Floaters (1866); Halo (2227); Posterior Capsule Opacification (4807)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the johnson and johnson (jnj) intraocular lens (iol) was implanted in the patient¿s right eye.The patient is experiencing floaters, rainbows, halos and starburst around lights and chrome colored objects.Patient was diagnosed with posterior capsule opacification and had a yag (yttrium-aluminum garnet laser treatment) and vitrectomy procedure.The implanting doctor informed her that she had abnormal inflammation in her eye and referred her to an expert.The second doctor stated there was nothing wrong with her eyes and that it was normal inflammation.The symptoms were noticed ¿right after the procedure¿ but the exact date is unknown.After the implants she could no longer drive at night.The patient reported that the only reason she did the implants was for better night vision but it¿s gotten significantly worse since the implants.She lives in a part of the country where it gets dark very early and she cannot go anywhere unless she is driven.The doctor said her brain needs time to adjust but it¿s been two years.The patient reviewed explanting the iols with her doctor.Reportedly, the doctor said, ¿in 24 years of practice he has never seen a lens replacement after a yag.¿ the doctor said that he can do the explants but will abort the procedure if he feels something may go wrong.The doctor also informed her that the iol can be replaced but she will have to wear glasses.The patient does not anticipate any problems and said she is a disabled but a healthy 60-year-old woman.No further information was provided.Note, the patient's experience for their left eye is reported in manufacturer report number: 3012236936-2024-0003069.
Additional Manufacturer Narrative
Section b3, date of event: the exact date is unknown.The patient said ¿right after the procedure¿.Section d6b, if explanted, give date: not applicable as the iol has not been explanted.Section h6- health effect - impact code: 4625 used to capture the unplanned vitrectomy and the yag (yttrium-aluminum garnet laser treatment) procedure.Section h3, device evaluated by manufacturer: the device was not returned for evaluation as it remains implanted.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 have been made to obtain the missing information.However, it was not available.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: through follow-up the customer provided the date of the vitrectomy for her right eye.This current report is to provide this information.The vitrectomy in her right eye was done (b)(6) 2024.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: upon further review it was determined that a correction for follow-up#1 is required as the following details are also applicable.This current report provides the correction below.Her second opinion doctor strongly suggested that the iol get explanted and replaced with a monofocal iol.The explant for the right eye is planned for january.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: 20720783
• Report Number: 3012236936-2024-000306
• Device Sequence Number: 12421903
• Product Code: MFK
• UDI-Device Identifier: 05050474750661
• UDI-Public: (01)05050474750661(17)241031
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/03/2024

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: 10/31/2024
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU195
• 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: 11/11/2024
• Supplement Date Received by Manufacturer: 12/03/2024; 12/03/2024
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 12/03/2024; 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/31/2021
• 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 Age: 62 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White