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

Model Number	ZMA00
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140); 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 the right eye due to "foggy and distorted and dislocated" lens.Another johnson & johnson iol was implanted as replacement (different model and different diopter, ar40e 22.0d).There was no patient injury and no medical or surgical intervention required.The patient is stable post-operatively.Through follow-up, it was learned that the iol dislocation was not due to device malfunction, however, no further information was available to clarify the event.
Additional Manufacturer Narrative
Unknown/asked but unavailable.Date of event: unknown/asked but unavailable.The best estimate date is between jan 31, 2022 and mar 15, 2022.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).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: apr 14, 2022.Section h3: evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification was performed and revealed that the lens was cut in half.The lens was cleaned and visually inspected under magnification and no additional issues were observed.No issues related to or could have contributed to visual issues were observed.Due to the returned condition of the lens (cut in half) no further product evaluation can be performed.During the complaint investigation, it was noticed that the product implant date was (b)(6) 2022, while the expiration date was march 16, 2014.Therefore, the product was used pass the expiration date.The iol shipping history was evaluated, and it was confirmed that the product was delivered at the account by april 15, 2011.Therefore, the issue was not related to a manufacturing, design, or shipping issue.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be verified.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: 14048766
• Report Number: 3012236936-2022-00916
• Device Sequence Number: 5994496
• Product Code: MFK
• UDI-Device Identifier: 05050474536890
• UDI-Public: (01)05050474536890(17)140316
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2022

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: 03/16/2014
• Device Model Number: ZMA00
• Device Catalogue Number: ZMA00U0245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/15/2022
• Supplement Date Received by Manufacturer: 07/08/2022
• Initial Report FDA Received Date: 04/07/2022
• Supplement Report FDA Received Date: 07/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2009
• 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 Sex: Female