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

Model Number	DFW225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dry Eye(s) (1814); Blurred Vision (2137); Visual Impairment (2138); Excessive Tear Production (2235); Posterior Capsule Opacification (4807)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a4, a5 and a6: unknown, information was requested but not provided.Section b3: date of event: unknown, not provided, but the best estimate date is between feb 14, 2024 and may 15, 2024.Section h3: the device was not returned for evaluation as it was discarded; 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, to date, the information has not been provided.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
A doctor reported that he intended to implant a symfony intraocular lens (iol) but implanted a synergy lens.It was confirmed that there was no mistake or error on the label of the device, that it was on doctor's paperwork.The doctor was not and is not concerned about the synergy lens being put in because he frequently does mix and match lenses.It was indicated that in the eye that has the synergy lens, the patient is.5 diopter hyperoptic.The patient did not have debilitating condition.The patient has very mild drusen and states that near vision that eye is blurry.The patient is fine, just not happy with the near/overall vision, has dry eye & tears are pooling in that eye.The patient put on artificial tears but did not make much of a difference.No outside of standard care medication was prescribed to the patient.It was noted that the capsule appears to be cloudy.The patient is 20/20 but again not happy with near vision in the eye which has the synergy lens.The doctor was considering an explant or yttrium-aluminum-garnet (yag) on that eye.In the second eye the doctor implanted a symfony optiblue lens and the patient is very happy with the vision in that eye.Additional information received indicated that yag was not been performed on the eye.However, the synergy lens was explanted and replaced with a symfony optiblue iol.The explanted lens was discarded at the customer site and is not available for evaluation.No further information was provided.

• 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: 19346851
• Report Number: 3012236936-2024-000144
• Device Sequence Number: 15076317
• Product Code: MFK
• UDI-Device Identifier: 05050474751804
• UDI-Public: (01)05050474751804(17)241005
• 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: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/17/2024

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: 10/05/2024
• Device Model Number: DFW225
• Device Catalogue Number: DFW225U175
• 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: 05/15/2024
• Initial Report FDA Received Date: 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/05/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female