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

Model Number	ZMA00
Medical Device Problem Codes	Break (1069); Scratched Material (3020)
Health Effect - Clinical Codes	Visual Impairment (2138); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a multifocal intraocular lens (iol) was implanted in a patient who developed double vision from a defect on the optic (looks like a scratch maybe loading) and a wonky haptic.The doctor noted that he needs to exchange.It was stated that the lens implanted is a +16.5 but the patient was hyperopic and iol was decentered.Further clarification noted that the doctor thought about exchange from the start but he tried to reposition the lens and rechecked ocular response analyzer (ora) which showed plano with the iol in place so he thought it was good.But the patient still measures +1.00 to +1.25 in the real world even since his first surgery.The doctor was going to do lasik but he cannot get the double image to go away even in a contact lens so the lens would need to come out anyway.It was noted later on that explant of iol occurred.No incision enlargement, no vitrectomy, no sutures done.No complications.The replacement lens used was same model but 1.0 diopter power size higher than the original io.This replacement iol helped address the visual issues of the patient.Patient tolerated the procedure well.No other information was provided.
Additional Manufacturer Narrative
Section a4: patient weight: unknown/ not provided.(b)(4).Section h3-other (81): the device 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.Section h6: health effect - clinical code: 2138 (to capture unexpected post-op refraction: and diplopia).Section h6: health effect - clinical code: 4581 (to capture device decentered or dislocated or tilted subluxated or wrong position).Attempts have been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: LENS, 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: 18298386
• Report Number: 3012236936-2023-03088
• Device Sequence Number: 12516907
• Product Code: MFK
• UDI-Device Identifier: 05050474536739
• UDI-Public: (01)05050474536739(17)250814
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 12/09/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/14/2025
• Device Model Number: ZMA00
• Device Catalogue Number: ZMA00U0165
• 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: 11/15/2023
• Initial Report FDA Received Date: 12/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2020
• 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: 73 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White