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

Model Number	DFR00V
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the johnson and johnson (jnj) intraocular lens (iol) has a crack in the optic.The iol was not explanted for risk of harm to the patient.The doctor reported the crack is minor and will not affect the patient¿s vision nor will it spread.There were no other complications reported.No further information was provided.
Additional Manufacturer Narrative
Section a2, a4, a5 patient information: customer declined to provide.Section d6b, if explanted, give date: not applicable as the iol remains implanted.Section h3-other (81): the device was not returned for evaluation as it remains implanted.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.
Event or Problem Description
Doctor stated, as you know, the intraocular lens (iol) comes already loaded in its injector.The technician that was working with me on the case, is very good and a very experienced technician.The viscoelastic was not added to the injector until the lens implant power had been confirmed with the ocular response analyzer (ora).After the lens implant unfolded, doctor noticed that there was a small crack in the optic of the iol.It was small and located a few rings away from the central ring, and determined that it would not cause a problem with the patient's vision.Doctor felt that the risk of removing the lens implant outweighed any potential problem that the crack might cause.Therefore, the lens was left implanted in its proper position in the capsular bag.Doctor reported that on the next postoperative day the patient was doing well and had not examined the patient since then.Doctor clarified that the lens implant was a low-power iol +12.0 diopter, so he does not think the thickness of the optic was a contributing cause of the crack.Doctor thinks that it must have been related to a problem with the injector.No further information was provided.
Additional Manufacturer Narrative
This is to correct the initial submission section b5.Upon further review it was determined the following information was also provided and should have also been included.Doctor stated, as you know, the intraocular lens (iol) comes already loaded in its injector.The technician that was working with me on the case, is very good and a very experienced technician.The viscoelastic was not added to the injector until the lens implant power had been confirmed with the ocular response analyzer (ora).After the lens implant unfolded, doctor noticed that there was a small crack in the optic of the iol.It was small and located a few rings away from the central ring, and determined that it would not cause a problem with the patient's vision.Doctor felt that the risk of removing the lens implant outweighed any potential problem that the crack might cause.Therefore, the lens was left implanted in its proper position in the capsular bag.Doctor reported that on the next postoperative day the patient was doing well and had not examined the patient since then.Doctor clarified that the lens implant was a low-power iol +12.0 diopter, so he does not think the thickness of the optic was a contributing cause of the crack.Doctor thinks that it must have been related to a problem with the injector.No further information was provided.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: 17892516
• Report Number: 3012236936-2023-02566
• Device Sequence Number: 15301153
• Product Code: MFK
• UDI-Device Identifier: 05050474750517
• UDI-Public: (01)05050474750517(17)250329
• 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 Implanted 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): 11/20/2023

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: 03/29/2025
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU120
• 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: 09/27/2023
• Supplement Date Received by Manufacturer: 11/12/2023
• Initial Report FDA Received Date: 10/07/2023
• Supplement Report FDA Received Date: 11/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2022
• 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