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

Model Number	DRN00V
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Scratched Material (3020)
Health Effect - Clinical Codes	No Clinical Signs, Symptoms or Conditions (4582); Posterior Capsule Opacification (4807)
Date of Event	04/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a3b, a4, a5, a6, patient information: asked, not available.Section h3, device evaluated by manufacturer: the device was not returned for evaluation as it remains implanted.Therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record and complaint trending for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.An attempt was made to obtain the missing information.However, it was not available.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the preloaded johnson and johnson (jnj) intraocular lens (iol) was implanted into the patient's eye.It was noticed that the iol had a scratch on the corner of the optic.The scratch caused resistance while implanting it.The iol remains implanted because the doctor felt it may not affect the patient's vision.There were no further complications or injuries such as a significant delay, capsule tear, vitrectomy, sutures or medication outside the standard of care.Preoperative and best corrected visual acuity is sc (without correction) : 20/50 ph (pinhole ocular): 20/30 ar:20/60 (ar: autorefractor) preoperative uncorrected and best corrected visual acuity?: sc (without correction) 20/40.The patient has been scheduled for a one month postoperative visit at which point their best corrected visual acuity will be checked again.No further information was provided.
Additional Manufacturer Narrative
Additional information: through follow-up the customer provided additional details.This current report is to provide this information.On (b)(6), 2025, the customer confirmed that the iol remains implanted.They did offer the patient an iol exchange however, the patient has pco (posterior capsule opacification) which is not causing blurry vision.They are considering performing a yag in a couple of months.Other than that, there is no commitment discussion being held.Section h6- health effect - clinical code: 4807 used to capture posterior capsule opacification.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information : section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: jun 10, 2025.Section h3: evaluated by manufacturer? yes.Device evaluation: the intraocular lens (iol) was not received as it remains implanted.The simplicity device was received and inspected.The customer provided photo was also evaluated.The complaint simplicity device was visually inspected under magnification revealing that the plunger rod was fully extended.The plunger rod tip was slightly bent.The cartridge was inspected and ovd was observed to be distributed throughout the cartridge, indicating that an adequate amount of ovd was used.No damage was observed on the cartridge.The lens module and handpiece were inspected and no issues were identified, and no resistance was felt while advancing the plunger rod.The customer provided photo was evaluated.The photo displays the suspect lens inside the patient's eye and crack-like marks were observed on the lens.Based on previous clinical advice, due to the location and characteristics of the marks, it is not expected to impact the optical function of the lens.However, the definitive impact and incident root cause cannot be determined from a photo assessment.Based on the complaint investigation results, the product was released within specifications.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be verified.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: 22092435
• Report Number: 3012236936-2025-000151
• Device Sequence Number: 15425197
• Product Code: MFK
• UDI-Device Identifier: 05050474810716
• UDI-Public: (01)05050474810716(17)271125
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 08/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DRN00V
• Device Catalogue Number: DRN00V0175
• 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: 04/29/2025
• Supplement Date Received by Manufacturer: 07/15/2025; 07/22/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 07/17/2025; 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2024
• 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
• Patient Age: 63 YR
• Patient Sex: Male