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

Model Number	DFW225
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Mechanical Jam (2983); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the preloaded intraocular lens (iol) came out ripped.There was patient contact.Through follow-up it was learned there was no use error and ovd was used.The lens initially moved a little when trying to advance and then stuck.There was no delay in surgery before an attempt to advance the lens.There was patient contact with the patient's left eye.Surgical time was longer because "the first lens" needed to be cut and removed.No further information was provided.
Additional Manufacturer Narrative
If implanted, give date: not applicable, as lens was removed/replaced during the same procedure.If explanted, give date: not applicable, as lens was removed/replaced during the same procedure.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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: through follow-up it was clarified that the surgeon had felt some resistance when advancing the lens.The lens was found ripped after it was fully inserted in the patient¿s eye, and then the lens was removed and replaced in the same procedure.The damaged lens was removed, which increased the surgical time.There was no patient injury and the patient is doing well.No further information was received.The following sections have been updated accordingly: section h6: health effect - impact code: 4632 - prolonged surgery.Corrected data: based on the additional information received, section h6: medical device problem code 2983 ¿mechanical jam¿ has been replaced with medical device problem code 1487 ¿device difficult to setup or prepare¿, as the complaint reporter clarified that the issue was that surgeon felt some resistance, not that the lens was stuck in the cartridge.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: dec 09, 2022.Section h3: evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification revealed that the complaint lens was received cut into three pieces, one of the haptics was cut as well.The lens was cleaned and, it could be observed to be damaged on the optic body.No additional issues were observed.Based on the return condition of the lens, no further product evaluation could be identified.The complaint issue "iol torn" and "difficult to use" were 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: 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: 15795802
• Report Number: 3012236936-2022-02842
• Device Sequence Number: 4649712
• Product Code: MFK
• UDI-Device Identifier: 05050474751712
• UDI-Public: (01)05050474751712(17)240910
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Followup
• Report Date (Section B): 01/17/2023

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: 09/10/2024
• Device Model Number: DFW225
• Device Catalogue Number: DFW225U130
• 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: 10/20/2022
• Supplement Date Received by Manufacturer: 11/17/2022; 12/23/2022
• Initial Report FDA Received Date: 11/15/2022
• Supplement Report FDA Received Date: 12/13/2022; 01/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2021
• 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: Female
• Patient Weight: 73 KG
• Patient Race: White