MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. 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 a4, a5 and a6: unknown, information was requested but not provided.Section b3: date of event: unknown, not provided, but the best estimate date is between january 20, 2026 and march 24, 2026.Section d4: catalog number: the complete catalog number is unknown, as the serial number was not provided.It was indicated that the lens was a drn00v.Section d4: serial number: unknown; information was requested but 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.Section h4: device manufacture date: unknown as product serial number was not provided.An attempt was made to obtain missing information; however, the information was not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a preloaded multifocal intraocular lens (iol), model drn00v, was implanted in the patient¿s left eye.The lens was subsequently explanted for unspecified reason during a secondary surgical procedure.The procedure was completed successfully with implantation of a replacement lens of a different model (dib00, +13.0 d).The patient¿s outcome is unknown.No additional medical or surgical interventions were indicated.No further information was provided.
Additional Manufacturer Narrative
Additional information: section b5: additional information received on may 20, 2026 provided that the product packaging box was received labeled with sn (b)(6) corresponds to the lens contained in the received plastic bag.Corrected data: the following fields were updated based on the additional information received.Section d4 (catalog number): drn00v0130, section d4 (serial number): (b)(6) section d4 (expiration date): february 18, 2028, section d4 (primary unique device identification (udi) number): (b)(4), section d9: device available for evaluation: yes, date returned to manufacturer: may 28, 2026.Section h4 (device manufacture date): february 18, 2025.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 PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 25010126
• Report Number: 3012236936-2026-000113
• Device Sequence Number: 21240647
• Product Code: MFK
• UDI-Device Identifier: 05050474810624
• UDI-Public: (01)05050474810624(17)280218
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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,Followup
• Report Date (Section B): 07/16/2026

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: DRN00V0130
• 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: 04/02/2026
• Supplement Date Received by Manufacturer: 05/20/2026; 06/23/2026
• Initial Report FDA Received Date: 04/27/2026
• Supplement Report FDA Received Date: 06/15/2026; 07/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DUOVISC.; DUOVISC.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female