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

Model Number	DCB00
Medical Device Problem Codes	Crack (1135); Ejection Problem (4009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a6, patient information: unknown/not provided.Section d6b, if explanted, give date: not applicable as the iol remains implanted.Section e1, telephone number: (b)(6).Entering the telephone number in h11 as the field only takes the us format.Section h3, device evaluated by manufacturer: the device has not been 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.Attempts have been made to obtain the missing information.However, to date, it has not been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the injector on the preloaded johnson and johnson (jnj) intraocular lens (iol) was defective.The iol was deployed in a more violent manner than usual and that in the peripheral part it looked like ¿splinters.¿ the doctor states that the injector was not perfectly smooth and that when inserting the lens, he observed a kind of splinter in its peripheral area.He also reports that the lens deployed violently.The customer examined the injector and noted some irregularity at the tip.The lens was placed in the patient and remains implanted.When the doctor sees the patient, he hopes not to have any problems since the defect is not in the optics.No further information was provided.
Additional Manufacturer Narrative
Device evaluation: the customer provided photos which were evaluated.The photos display the suspect product cartridge and the plunger rod can be observed to be fully advanced.The cartridge tip can be observed to be deformed.Due to no product received, no further evaluation could be performed, and no further issues could be identified.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: 20364212
• Report Number: 3012236936-2024-000269
• Device Sequence Number: 14389191
• Product Code: HQL
• UDI-Device Identifier: 05050474636040
• UDI-Public: (01)05050474636040(17)260401
• Combination Product (Y/N): N
• Initial Reporter Country: UY
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2024

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 Expiration Date: 04/01/2026
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000180
• 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: 09/30/2024
• Supplement Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 11/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2023
• 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 Sex: Unknown