MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS SIMPLICITY; INTRAOCULAR LENS

Model Number	DIB00
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the johnson and johnson (jnj) intraocular lens (iol) had a scratch.The doctor noticed the scratch after the iol was implanted.Since the scratch is in the periphery of the iol the doctor decided to leave it.The doctor feels it will not affect the patient¿s vision.The iol remains implanted in the patient¿s left eye.There were no complications such as a capsule tear, vitrectomy incision enlargement or sutures.No further information was provided.
Additional Manufacturer Narrative
Section a3b gender: the customer responded.¿we don¿t collect that information since most of our patients are on the older side.¿ section a4, weight: unknown/not provided.Section a5, ethnicity: unknown/not provided.Section a6, race: unknown/not provided section d6b, if explanted, give date: not applicable as the iol remains implanted.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, 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.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.
Additional Manufacturer Narrative
Additional information.Section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: oct 9, 2024.Section h3: evaluated by manufacturer: yes.Device evaluation: the complaint device was received in a bag.No lens was received.Only the preloaded cartridge was received.This is considered a partial return.The device was inspected under magnification.The device was received with the plunger rod fully advanced.Viscoelastic residue was distributed through the length of the cartridge and no cartridge damage was identified.The lens module was inspected and presented with no viscoelastic residue or damage.The device assembly was inspected and presented with no issues.Plunger rod advancement was inspected and no resistance was identified.No lens was returned for evaluation.The customer provided photo was evaluated by a post market safety surveillance officer.The picture shows an eye being implanted with an intraocular lens claimed to be a tecnis eyhance iol preloaded in a simplicity delivery system, model dib00.Due to the quality of the picture, the reported issue cannot be observed.The clinical impact and potential root cause of the reported issue cannot be determined from the picture 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: INTRAOCULAR LENS
• 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: 20232491
• Report Number: 3012236936-2024-000252
• Device Sequence Number: 12784800
• Product Code: HQL
• UDI-Device Identifier: 05050474731691
• UDI-Public: (01)05050474731691(17)270701
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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
• Report Date (Section B): 12/10/2024

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: DIB00
• Device Catalogue Number: DIB00U0170
• 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: 09/16/2024
• Supplement Date Received by Manufacturer: 11/22/2024
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2024
• 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: 68 YR
• Patient Sex: Male