MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS IOL; EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS

Model Number	ZXR00V
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted, give date: not applicable as the device was not implanted.If explanted, give date: not applicable as the device was not implanted therefore not explanted.Device evaluation: product evaluation was not performed because the product has not been received.The complaint issue reported could not be confirmed and no product deficiency could be identified.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed that no other complaints were received from this production order.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.Attempts have been made to obtain the missing information.However, to date it has not been received.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.
Event or Problem Description
Customer reported that when they inserted the intraocular lens (iol) into the patient¿s eye they noticed the optic was torn.The iol was cut out of the eye.There were no injuries reported.No vitrectomy, sutures, or incision enlargement.A backup iol of the same model and diopter was used to complete the procedure.No further information was provided.
Additional Manufacturer Narrative
Additional information: upon further review it was noted that section h3: device evaluated by manufacturer box was inadvertently not indicated in the initial report # 3012236936-2022-02857 submitted.Field below updated to correct this info.Section h3: device evaluated by manufacturer: yes.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: EXTENDED DEPTH OF FOCUS 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: 15920833
• Report Number: 3012236936-2022-02857
• Device Sequence Number: 4383892
• Product Code: POE
• UDI-Device Identifier: 05050474734081
• UDI-Public: (01)05050474734081(17)251001
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 12/05/2022

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: 10/01/2025
• Device Model Number: ZXR00V
• Device Catalogue Number: ZXR00VU180
• 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: 12/05/2022
• Supplement Date Received by Manufacturer: 12/05/2022
• Initial Report FDA Received Date: 12/05/2022
• Supplement Report FDA Received Date: 12/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2020
• 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
• Patient Sex: Unknown