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

Model Number	DRT150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Flashers (1864); Blurred Vision (2137); Halo (2227)
Date of Event	03/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a2, a3, a3b, a4 and a5: unknown/ asked but not available.Section e1:surgeon's phone number: unknown/ asked but not available.Device evaluation: at the time of the investigation, device was not available for evaluation, therefore no testing could be performed.The reported event cannot be confirmed.Manufacturing record review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.Conclusion: based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the preloaded intraocular lens (iol) was explanted from patient's right eye as the patient complained of starburst, halos, blurred vision at all distances.The lens was explanted in a secondary procedure and replaced with drn00v lens.Patient doing better now.Patient claimed vision was improving.From additional information it was learnt that lens had contributed for blurred vision, halos and starbursts.The daily activities of the patient were affected.There were no any debilitating conditions with the patient.The replaced lens had satisfied/correct the patient¿s issues.There was no patient injury.There was no medical/surgical intervention required.No other information is available.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: 4/24/2025.Section h3: device evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification was performed on the suspect product and found the lens was received cut in half and coated in viscoelastic residue.The lens halves were cleaned revealing no issues that could cause or contribute to the complaint issue reported.No further evaluation was performed.Conclusion: no issues that could cause or contribute to the complaint issues reported were identified during product evaluation.The "lens cut" observed during the product evaluation could not be confirmed to be related to the manufacturing or design process.Based on the complaint investigation results, the product was released within specifications.No product deficiency or product malfunction could be identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: upon further review it was noted that section g4: pma/510(k) number in the initial mdr was inadvertently submitted missing the ¿p¿ before the numerical value.The complete number is p980040.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS ODYSSEY TORIC II 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: 21875535
• Report Number: 3012236936-2025-000104
• Device Sequence Number: 7719243
• Product Code: MFK
• UDI-Device Identifier: 05050474811324
• UDI-Public: (01)05050474811324(17)260912
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: 2025
• 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): 01/08/2026

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: 09/12/2026
• Device Model Number: DRT150
• Device Catalogue Number: DRT1500185
• 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: 03/26/2025
• Supplement Date Received by Manufacturer: 05/23/2025; 12/15/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 06/18/2025; 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2023
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 111 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White