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 Code	Blurred Vision (2137)
Date of Event	05/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section h3: the device was not returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of records including device history and complaint trending will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Section h6: health effect - clinical code: 2137- blurred vision- used to indicate blurred vision and poor near vision.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a patient underwent an odyssey toric intraocular lens (iol) exchange due to dissatisfaction with near/intermediate vision and felt that she could not read well despite a qualitative outcome.The original lens was replaced with non-j&j lens.The affected eye was the left eye (os).Pre-op uncorrected and best corrected visual acuity was 20/40 and 20/50.Post-op uncorrected and best corrected visual acuity 1 day post-op iol exchange was 20/30-2, j1.Post-exchange, the patient¿s uncorrected and best-corrected visual acuity improved from j2 pre-exchange to j1 on post-op day 1.No patient injury or debilitating condition.No other medical or surgical interventions were not required.The patient was doing well post-operatively.No further information is available.
Additional Manufacturer Narrative
The product was returned to the manufacturing site for evaluation.Additional information: section d9: device available for evaluation? yes section d9: date returned to manufacturer: sep 30, 2025 section h3: evaluated by manufacturer: yes device evaluation: visual inspection under magnification was performed on the suspect product and found the lens was cut in half and coated in viscoelastic residue.The lens was cleaned and inspected and no issues were identified.No further evaluation was performed.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.Manufacturing record review: the manufacturing records review for this po shows that the units were released within specification.Conclusion: 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 (b)(4).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: 22999865
• Report Number: 3012236936-2025-000238
• Device Sequence Number: 15702700
• Product Code: MFK
• UDI-Device Identifier: 05050474811232
• UDI-Public: (01)05050474811232(17)271126
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 01/09/2026

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: DRT1500140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 08/15/2025
• Supplement Date Received by Manufacturer: 10/03/2025; 12/15/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 10/28/2025; 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2024
• 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