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

Model Number	DRN00V
Medical Device Problem Codes	Application Program Problem: Dose Calculation Error (1189); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Flashers (1864); Blurred Vision (2137)
Date of Event	02/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a2 and a4: unknown, information not provided.Section d6b: if explanted, give date: unknown, information not provided.Section e1: reporter: middle name: unknown, information not provided.Section e1: reporter: email address: unknown, information not provided.Section e1: reporter: address: address - line 2: unknown, information not provided.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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that odyssey intraocular lens (iol) 22.0d was explanted in secondary procedure and replaced with same model lens with 23.5d.Patient had trouble reading due to wrong power iol.There was unplanned incision enlargement.Unplanned sutures were required.Pre-operative best corrected visual acuity (bscva) was 20/20 and post-operative bscva was 20/20.Patient was temporarily impaired.No unplanned vitrectomy was required.There was no delay in procedure.No further information was provided.
Additional Manufacturer Narrative
Corrected data and additional information: section b5: additional information received on 5/22/2025 stated that there was improvement in patient's vision.Near vision was better and patient was no longer having positive dysphotopsias.Wrong diopter was calculated.For the first iol both pre-op calculations and the ora (ocular residual astigmatism calculator) determined an iol for plano that actually ended up being slightly hyperopic.So patient's near vision was not good after the first placement.For the exchange, power was increased and patient is now happier.D6b.If explanted, give date: (b)(6) 2025.E1:reporter name and address: email address: (b)(6).Section h6: health effect - clinical code: the code '1864 - flashers' has been added.Section h6: device code(s): the code '1189 - application program problem: dose calculation error' has been added.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS SIMPLICITY
• 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: 22074099
• Report Number: 3012236936-2025-000149
• Device Sequence Number: 13095805
• Product Code: MFK
• UDI-Device Identifier: 05050474810815
• UDI-Public: (01)05050474810815(17)270731
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2025

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: DRN00V
• Device Catalogue Number: DRN00V0225
• 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: 04/24/2025
• Supplement Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/31/2024
• 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
• Patient Ethnicity: Non Hispanic
• Patient Race: White