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

Model Number	ZCT400
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a product complaint confirmed in an unmasked clinical study had some concerns on axis position of lens in os (left eye).8° at the end of surgery, 33° at 1 day postop, 13° at 1 week postop, 18° at 1 month postop, and 23° at 3 months postop.The site also reported that there was moderate corneal edema at day 1 which did limit the visualization of the toric axis markers.It was stated that at the 1 month postoperative visit, the toric iol was noted to have rotated by 10°.Toric iol confirmed to have rotated 10 degrees between the end of surgery and the 1 month postoperative visit.The customer confirmed via email on 02 feb 2023 that they were monitoring it and wouldn¿t be completing a secondary surgical intervention.It was learned that the lens remains implanted.Patient not symptomatic, no issues.No next action planned so far.These were observed during post-op examination.Vision pre-operative:20/40 left eye (os); best corrected distance visual acuity (bcdva); vision post-operative:20/60 os bcdva.No other information was provided.
Additional Manufacturer Narrative
Unknown/ not provided.Asku.If explanted, give date: not applicable, as the lens remains implanted.Initial reporter's email address: unknown/not provided.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.An attempt has 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.
Additional Manufacturer Narrative
Information received that age of the patient is (b)(6) yrs.Old.Field below updated.Section a2: age: (b)(6) yrs.Old.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 16645698
• Report Number: 3012236936-2023-00792
• Device Sequence Number: 14794377
• Product Code: MJP
• UDI-Device Identifier: 05050474553941
• UDI-Public: (01)05050474553941(17)240227
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Study,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/27/2024
• Device Model Number: ZCT400
• Device Catalogue Number: ZCT400U215
• 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: 01/31/2023
• Supplement Date Received by Manufacturer: 03/29/2023
• Initial Report FDA Received Date: 03/30/2023
• Supplement Report FDA Received Date: 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNFOLDER PLATINUM 1.
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian