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

Model Number	DCB00
Medical Device Problem Code	Inaccurate Delivery (2339)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted, give date: not applicable, as there was no indication that the lens was implanted.If explanted, give date: not applicable, as there was no indication that the lens was implanted, therefore, not explanted.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.Attempts were made to obtain the missing information; however, no additional information has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the preloaded intraocular lens (iol) ejected too early.There was patient contact.No further information was provided.
Additional Manufacturer Narrative
Additional information: the following sections have been updated accordingly: section a2: age: (b)(6) year(s) section a2: date of birth: (b)(6) 1952.Section b5: there was no injury to the patient.Section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: mar 10, 2023.Section e1: reporter name and address: title (e.G., mr., ms.): dr.Section e1: reporter name and address: first/given name: (b)(6).Section e1: reporter name and address: last name: (b)(6).Section e1: telephone number: (b)(6).Section e2: health professional? yes.Section e3: occupation: physician.Section h3: evaluated by manufacturer: yes.Device evaluation: the product was received for evaluation.Visual inspection under magnification revealed that the complaint handpiece was received with the lens stuck half out of the cartridge tip.The plunger rod could be observed to be advanced to the edge of the lens.The handpiece was disassembled and the assembly was inspected, no issues that could contribute to or cause the complaint or observed issues.The lens was removed from the cartridge and cleaned, revealing that the lens was torn and damaged.The complaint issue uncontrolled delivery was not identified during product evaluation.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Therefore, there is no indication of a product deficiency or product malfunction.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: 16535057
• Report Number: 3012236936-2023-00654
• Device Sequence Number: 5945892
• Product Code: HQL
• UDI-Device Identifier: 05050474636194
• UDI-Public: (01)05050474636194(17)250730
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 04/14/2023

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: 07/30/2025
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000255
• 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: 02/17/2023
• Supplement Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 03/13/2023
• Supplement Report FDA Received Date: 04/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2022
• 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: 70 YR
• Patient Sex: Unknown