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

Model Number	DRT150
Medical Device Problem Code	Application Program Problem: Dose Calculation Error (1189)
Health Effect - Clinical Codes	Visual Impairment (2138); Prolapse (2475)
Date of Event	06/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: section a-3b patient gender: unknown/asked information was not provided.Section a-6 patient race: unknown/asked information was not provided.Section b-3 date of event: unknown/asked information was not provided.The best date estimation is between 11-jun-2025 and 25-jun-2025 (iol implant and explant dates).Section h-3 device evaluated by manufacturer: the complaint 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 report will be filed.Attempts were made to contact the customer account requesting additional information regarding complaint however, to date no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
The drt150 model intraocular lens (iol) was implanted in the patient¿s ocular dexter (right eye).In a secondary surgical procedure, the iol was explanted due to complaints of refractive surprise and replaced with a drt150 24.0 iol.The wrong lens was chosen due the patient having prior lasik procedure and the doctor was not aware of this.During the lens exchange procedure there was no patient injury and no vitrectomy however, the iris prolapsed, was placed back in the eye, and 1-2 sutures were required to keep the iris in the eye.Patient prognosis post lens exchange was reported as patient in post-op recovery, as well as can be.No further information is available.
Additional Manufacturer Narrative
Additional information was received, confirming lasik procedure was performed in 2006, prior to implantation of the original drt150 iol.During the lens exchange procedure, the incision was enlarged and the use of sutures was a prophylactic measure.Patient visual acuity post lens exchange was reported as 20/25.Therefore, the newly received information will be captured in this supplemental report.No further information is available.The following sections have been updated accordingly: section a-3b patient gender: female.Section a-6 patient race: hispanic.Section b-3 date of event: 23-jun-2025.Device evaluation: product evaluation was not performed because the product has not been received.If product is received after initial closure, the pi and cp (if necessary) may be re-opened to complete the return investigation.The complaint issue reported could not be confirmed.The manufacturing records for the product were reviewed; the units were released in accordance with specifications.The search revealed that no other complaints were received for this production order (po) number.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
Additional information: section d-9: device available for evaluation: yes.Section d-9: device date returned to manufacturer: 05-aug-2025.Section h-3: device evaluated by manufacturer: yes.Device evaluation: the complaint lens was received inside a specimen cup.During a visual inspection, the device was inspected under magnification.The lens was received coated in viscoelastic residue and what appears to be dried blood.The lens was cleaned revealing no issues that could cause or contribute to the complaint issue reported.The complaint issue "dc-calculation issue" could not be confirmed during product evaluation, and no issues were identified.The manufacturing records for the product were reviewed; the units were released in accordance with specifications.A search revealed that no other complaints have been received for this production order (po) number.Conclusion: based on the complaint investigation results, the product was released within specifications.No product deficiency or product malfunction was 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: 22572393
• Report Number: 3012236936-2025-000200
• Device Sequence Number: 9528794
• Product Code: MFK
• UDI-Device Identifier: 05050474811515
• UDI-Public: (01)05050474811515(17)280206
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,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: DRT1500280
• 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: 06/25/2025
• Supplement Date Received by Manufacturer: 08/04/2025; 08/08/2025; 12/15/2025
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 08/04/2025; 08/24/2025; 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2025
• 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
• Patient Weight: 56 KG
• Patient Ethnicity: Hispanic