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

Model Number	ZKB00
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Blurred Vision (2137); Zonular Dehiscence (2698); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a4: patient weight: unknown; requested but not provided.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: code 4581 is to capture device decentered or dislocated or tilted subluxated or wrong position.Attempts were made to obtain the missing information; however, no additional information has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the intraocular lens (iol) was explanted from the right eye in a secondary procedure due to dislocation.Another johnson and johnson iol was implanted as replacement (different model zma00, different diopter 17.5).There was no patient injury and no additional medical or surgical intervention was required.Through follow-up, it was learned that at the first post-op visit on the same day the lens was implanted, the lens was well centered.On the next day, (b)(6) 2023, the patient called the surgeon reporting that the eye was rubbed accidentally (hard enough to scare the patient) and the patient started to experience blurry vision.The patient had a follow-up visit the same day and it was noted that the lens was partially subluxed due to a compromised capsule.The surgeon stated that it is possible that the patient may have rubbed the eye hard enough to dislocated the lens, but the surgeon cannot confirm that this was the cause.The patient does not have any pre-existing conditions that may have contributed to the event.An iol exchanged was needed and a three piece lens (zma00) was implanted in the sulcus, "just to be safe".The surgery was uncomplicated.The patient is doing great post-operative, with 20/20 vision in that eye.The surgeon does not think anything was wrong with the iol itself.No further information was provided.
Additional Manufacturer Narrative
The product was received for evaluation.Additional information was reported that amvisc viscoelastic was used during surgery.No further information was provided.The following fields have been updated accordingly: section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: aug 15, 2023.Section d10: concomitant medical products: amvisc viscoelastic.Section h3: evaluated by manufacturer: yes.Device evaluation: the complaint lens was received wrapped in gauze.Visual inspection revealed that the lens was received cut but not separated.The lens was cleaned and no issues that could cause or contribute to the complaint issue could be identified.No further product evaluation could be performed based on the return condition of the lens.The complaint issue "instability of device after implantation" was not identified during product evaluation.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Therefore, there is no indication of a product deficiency or product malfunction.Conclusion: based on the complaint investigation results, the product was released within specifications.The complaint issue reported could not be confirmed and no product deficiency or product malfunction could be identified.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: 17553675
• Report Number: 3012236936-2023-02099
• Device Sequence Number: 4880201
• Product Code: MFK
• UDI-Device Identifier: 05050474560048
• UDI-Public: (01)05050474560048(17)270125
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2023

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 Model Number: ZKB00
• Device Catalogue Number: ZKB00U0180
• 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: 07/26/2023
• Supplement Date Received by Manufacturer: 09/08/2023
• Initial Report FDA Received Date: 08/15/2023
• Supplement Report FDA Received Date: 09/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2023
• 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: AMVISC VISCOELASTIC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White