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

Model Number	ZCU375
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Eye Injury (1845)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an intraocular lens (iol) was explanted from the patient's operative eye due to a patient complaint.No other information was provided.
Additional Manufacturer Narrative
Information unknown/not provided.The exact date is unknown, the best estimate is prior to (b)(6) 2022.If implanted; give date: unknown/not provided.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.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.
Additional Manufacturer Narrative
Additional info: section d9: device available for evaluation? yes.Section d9: returned to manufacturer on: 7/1/2022.Section h3: device evaluated by manufacturer¿ yes.Device evaluation: the complaint lens was received inside of an open sterilization pouch.Visual inspection under magnification revealed that the complaint lens was received coated in viscoelastic residue.The lens was cleaned and scratches could be identified on the optic body.No further issues were identified.The complaint issue of explant and unspecified injury were not confirmed.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: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be confirmed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: INTRAOCULAR LENS
• 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: 14780556
• Report Number: 3012236936-2022-01660
• Device Sequence Number: 11972769
• Product Code: HQL
• UDI-Device Identifier: 05050474700468
• UDI-Public: (01)05050474700468(17)241107
• 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 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
• Report Date (Section B): 10/10/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/07/2024
• Device Model Number: ZCU375
• Device Catalogue Number: ZCU375U150
• 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: 06/02/2022
• Supplement Date Received by Manufacturer: 09/15/2022
• Initial Report FDA Received Date: 06/22/2022
• Supplement Report FDA Received Date: 10/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2019
• 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: Unknown