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

Model Number	DFR00V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140); Halo (2227)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a4: unknown/ not provided.Asku.Section b3: date of event: unknown, not provided.Section d6b: if explanted, give date: not applicable, as lens remains implanted and not explanted.Section h3: the device was not returned for evaluation, as lens 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.Attempts have been made to obtain the missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the preloaded tecnis synergy intraocular lens (iol) was explanted from the patient's right eye (od) due to intolerable visual side effects of the iol implant.It was learned that the visual symptoms were blurry vision and halos.The lens was replaced with a monofocal iol of the same diopter power size as the original iol.Patient outcome from the replacement iol noted as patient much happier.Additionally, it was noted that the left eye (os) was also implanted with the same model and diopter size as the one implanted in the right eye.It was learned that the visual symptoms for os were also blurry vision and halos which the patient is still experiencing as the iol remains implanted in the os.It was noted that the extent of visual symptoms made the patient unable to read and have issues with distance vision.No other information was provided.This mdr report pertains to the left eye (os).A separate report will be submitted for the right eye (od).
Additional Manufacturer Narrative
Additional information: new information received that suspect lens for left eye (os) was explanted and replaced with a dib00 20.0d intraocular lens.No other information was provided.Field below is updated.Section h6: health effect: impact code: 4629.Section h6: health effect: clinical code: 2140 (to capture hm-visual disturbance- dysphotopsia- requiring surgical intervention: visual impairment).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information and corrected data: in review, it was determined, that section d6b: explant date was missed to be populated in the previous report submitted.Explant date was (b)(6) 2024.Also, since explant was performed as reported, this info.Was not updated in the appropriate fields in 1st supplemental report section h6.Therefore, this supplemental report is being submitted to add the missed sections.Fields below are updated: section d6b: if explanted, give date: (b)(6) 2024.Section h6: type of investigation: 4114, 3331 and 4109.Section h6: investigation findings: 213.Manufacturing record review: the manufacturing process record was evaluated and revealed, that the product was manufactured and released according to specifications.A search of complaints related to this production order was performed in the system.The search revealed, one complaint file but is not related.Based on complaint handling record results, no further actions are required.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: 19630178
• Report Number: 3012236936-2024-000178
• Device Sequence Number: 18283495
• Product Code: MFK
• UDI-Device Identifier: 05050474750661
• UDI-Public: (01)05050474750661(17)240823
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• 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): 07/25/2024

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: 08/23/2024
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU195
• 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: 06/24/2024
• Supplement Date Received by Manufacturer: 07/19/2024; 07/25/2024
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 07/23/2024; 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/23/2021
• 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 Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White