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

Model Number	DRN00V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Eye Injury (1845)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a2: age and date of birth: unknown/not provided.Section a3a: sex: unknown/not provided.Section a3b: gender: unknown/not provided.Section a4: weight: unknown/not provided.Section a5: ethnicity: unknown/not provided.Section a6: race: unknown/not provided.Section b3: date of event: unknown/not provided.The best estimate date is between april 7, 2025 and oct 14, 2025.Section d4: model number: unknown/not provided.Section d4: catalog number: unknown, as the serial number was not provided.Section d4: serial number: unknown/not provided.Section d4: expiration date: unknown, as the serial number was not provided.Section d4: unique identifier (udi) number: unknown, as the serial number was not provided.Section h3: the device was not returned for evaluation and the serial number for this device is unknown/not provided; therefore, no further product investigation can be performed.Should any further relevant information become available a supplemental medwatch will be filed.Attempts have been made to obtain missing information; however, to date, no additional information has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that an preloaded multifocal intraocular lens (iol) was explanted from the right due to an unknown reason.Patient status is unknown.No further information was provided.
Additional Manufacturer Narrative
Additional information: additional information received indicated that the device was cut and discarded.The following field was updated accordingly: section h6: type of investigation: 4115 corrected data: upon review, it was identified that the verbiage for section h4 was inadvertently omitted from section h11 in the initial mdr.Additionally, section f7 (type of report) was incorrectly selected as an initial report; this field should have been left blank.This supplemental mdr is submitted to correct these inaccuracies.Section h4: device manufacture date: unknown, as the product serial number was not provided.The following code is no longer applicable based on the additional information provided: section h6: type of investigation: 4114 - device not returned all pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: additional information received indicated that the serial number of the complaint device was (b)(4).Corrected data: in review, it was noted that the sn (8089752433) of the complaint device was inadvertently not included in the follow-up mdr report #1; therefore, the information has been captured in this supplemental mdr report.The following fields were updated accordingly: section d1: brand name: tecnis simplicity.Section d3: manufacturer establishment name: amo manufacturing netherlands.Section d3: manufacturer country: other (netherlands).Section d3: manufacturer address - line 1: van swietenlaan 5.Section d3: manufacturer city: groningen.Section d3: manufacturer state, province or territory: groningen.Section d3: manufacturer postal office or zip code: 9728 nx.Section d4: model number: drn00v.Section d4: catalog number: drn00v0195.Section d4: serial number: (b)(6).Section d4: expiration date: aug 16, 2027 section d4: unique identifier (udi) number: (b)(4).Section h4: device manufacture date: aug 16, 2024.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 PR 9728 NX; NL 9728 NX
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 23490042
• Report Number: 3012236936-2025-000286
• Device Sequence Number: 8552422
• Product Code: MFK
• UDI-Device Identifier: 05050474810754
• UDI-Public: (01)05050474810754(17)270816
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 04/29/2026

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: DRN00V
• Device Catalogue Number: DRN00V0195
• 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: 10/14/2025
• Supplement Date Received by Manufacturer: 04/21/2026; 04/21/2026
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 04/29/2026; 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2024
• 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: Unknown