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

Model Number	DRN00V
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after the preloaded intraocular lens (iol) was implanted the surgeon noticed a defect that looked like a chip or scratch on the periphery of the lens.The surgeon decided against removal due to the associated risks (explant would have outweighed the benefit, discomfort or visual issues noticed).The scratched was described to be about 0.5 mm from the optic edge, far enough on the periphery where the surgeon felt it was out of the visual axis.
Additional Manufacturer Narrative
Section a2, a3, a3b, a4 and a5: unknown/ asked but not available.Section d6a: if implanted, give date: unknown, information not provided.Section d6b: if explanted, give date: not applicable, remains implanted in the eye.Section h3: the device was not returned for evaluation.Therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device 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.
Additional Manufacturer Narrative
Upon further additional response supplemental mdr will be updated accordingly with the aware date of 10/13/2025.The following fields have been updated accordingly: section a: age: dob: (b)(6) 1968.Section a4.Weight: 115 pounds.Section a5.Ethnicity : hispanic/latino.Section a6: race: while.Section b5: describe event or problem: unable to tolerate the optics of a multifocal lens implanted on (b)(6) 2025, with the explant performed on (b)(6) 2025.The patient needed unplanned vitrectomy.This patient was reported fully recovered post-explant.Iol was destroyed and unavailable for return.Section h6: health effect - impact code:4625 - additional surgery.Section h6: health effect - clinical code: 2140 - visual disturbances.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Section a2: 56 years.Section a3: female.Section b5: describe event or problem: additional information revealed that postoperatively, the patient experienced visual disturbances described as "vaseline-type vision," blurry vision at all distances, and seeing the edges of tubes in her peripheral vision.Despite these issues, the patient achieved a visual acuity of 20/20 for distance, 20/30 for near, and 20/25 for intermediate vision binocularly at six months post-operation.Due to these disturbances, patient met with surgeon and wanted to proceed with a lens exchange.Lens explant was done on (b)(6) 2025 and a 29.5 aspire monofocal iol was inserted.The odyssey iol that was explanted was destroyed.The patient is doing well postoperatively.Section d6a.If implanted, give date: (b)(6) 2025.Section d6b.Explanted, give date: (b)(6) 2025.Section h6: health effect - impact code: 4629 - device revision or replacement.Section h6: health effect - clinical code: 2137 - blurred vision.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: 21333854
• Report Number: 3012236936-2025-000031
• Device Sequence Number: 3849414
• Product Code: MFK
• UDI-Device Identifier: 05050474810945
• UDI-Public: (01)05050474810945(17)271121
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,Followup
• Report Date (Section B): 11/11/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: DRN00V
• Device Catalogue Number: DRN00V0290
• 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: 01/15/2025
• Supplement Date Received by Manufacturer: 10/13/2025; 10/13/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 11/04/2025; 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/20/2024
• 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 Age: 56 YR
• Patient Sex: Female
• Patient Weight: 52 KG
• Patient Ethnicity: Hispanic
• Patient Race: White