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	Dry Eye(s) (1814); Visual Impairment (2138)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was dissatisfied with their best corrected visual acuity (bcva) after receiving a preloaded toric intraocular lens.They experienced a hyperopic surprise, despite the surgeon confirming that all measurements and calculations were accurate.Their manifest refraction (mrx) was +2.50 sph, and their significant dry eye condition, which had been treated and stabilized over six months, showed no change in measurements.Due to the unexpected hyperopia and lack of a clear explanation, a decision was made to target approximately -2.50 diopters for future correction.The initial lens was explanted and replaced with another preloaded toric lens of 25 diopters.Since the lens exchange, the patient's vision has improved significantly, and they have expressed much greater satisfaction.Their current refraction is now -2.25 se, suggesting there may have been an abnormality with the initially delivered lens.No additional information was provided.
Additional Manufacturer Narrative
Section a2, a3b, a4, a5 and a6: unknown/information not provided.Section b3: date of event: unknown/information not provided.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection revealed that the lens was cut with a cut portion of the lens missing.No other issues were identified.No issues that could cause or contribute to the complaint issues reported were identified during product evaluation.Manufacture record review: the manufacturing records review shows that the units were released within specification.No process deviations (dev), nonconformances (nc/nr), or capas were found as part of this manufacturing records review.Conclusion: based on the complaint investigation results, the product was released within specifications.The complaint issue reported could not be confirmed and 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: 22578106
• Report Number: 3012236936-2025-000201
• Device Sequence Number: 21141582
• Product Code: MFK
• UDI-Device Identifier: 05050474811379
• UDI-Public: (01)05050474811379(17)270521
• 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: 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
• Report Date (Section B): 01/09/2026

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 Model Number: DRT150
• Device Catalogue Number: DRT1500210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2025
• 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: 06/24/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2024
• 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: Female