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

Model Number	ZMA00
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the intraocular lens (iol) was explanted from a patient's left eye due to decentered lens.No further information was provided.
Additional Manufacturer Narrative
Weight, ethnicity information was asked but not provided.Date of event: unknown/not provided, but the best estimate date is between jul 15, 2022 and aug 15, 2022.Device evaluated by mfr: the device was not returned for analysis.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.(b)(4).Attempts have been made to obtain suspect product for evaluation as well as the missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: in review, it was noticed that an incorrect date (oct 5, 2022) was inadvertently entered in section "b4 -date of this report" of the initial mdr report.The correct date that should have been entered is oct 6, 2022.This supplement is being submitted to correct that information.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.
Additional Manufacturer Narrative
Additional information: additional information received indicated compromised posterior capsule precluding in the bag fixation occurred.The zma00 lens haptics were sulcus fixated and the optic was captured by the anterior capsule.The lens was well centered at the time of surgery as wll as on day one (1) and the second post op visit.It was indicated that the device decentration first noticed 1-2 weeks post operation.At the time the lens was removed a posterior vitrectomy was performed, the lens explanted and a monofocal lens inserted with good haptic fixation in the sulcus and anterior capsule capture of the haptic.Suture fixation was not needed.It was reported that the posterior capsule was compromised at the first surgery precluding in the bag fixation.The patient outcome post explant was reported to be very well.20/25 happy.Quiet anterior segment, no retina pathology.The following fields were updated accordingly: section b3: date of event: unknown/not provided, but the best estimate date is 1-2 weeks post operation.Section h6: health effect - clinical code: 2639 - capsular bag tear.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: 15458485
• Report Number: 3012236936-2022-02437
• Device Sequence Number: 17895354
• Product Code: MFK
• UDI-Device Identifier: 05050474536852
• UDI-Public: (01)05050474536852(17)250211
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/06/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/11/2025
• Device Model Number: ZMA00
• Device Catalogue Number: ZMA00U0225
• 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: 08/24/2022
• Supplement Date Received by Manufacturer: 09/19/2022; 09/19/2022
• Initial Report FDA Received Date: 09/20/2022
• Supplement Report FDA Received Date: 10/06/2022; 10/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2020
• 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: 70 YR
• Patient Sex: Male