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

Model Number	DCB00
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an intraocular lens (iol) cartridge tears at the end while inserting the lens into the patient's operative eye.This occurs as the surgeon screws the lens through into the eye.The implant also has some small little defects on it.The surgeon sees abnormalities on the lens.Nurse assured she filled the cartridge with balanced salt solution (bss) and sat for more than 3-5 minutes.
Additional Manufacturer Narrative
Model number: a complete model is unknown, as the serial number was not provided.Catalog number: a complete catalog number is unknown, as the serial number was not provided.If implanted, give date: unknown/not reported; it is unknown if the iol had any patient contact or if it was implanted.If explanted, give date: unknown/not reported; it is unknown if the iol had any patient contact or if it was implanted.Initial reporter telephone number: (b)(6).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.An attempt has been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional info: further information was provided and reported the date of event and the serial number was provided.The surgeon also reported he still used the iol.No other information was provided.The following sections have been updated accordingly: section b3: date of event: feb 8, 2023.Section d4: model number: dcb00.Section d4: catalog number: dcb0000135.Section d4: serial number: (b)(6).Section d4: expiration date: nov 20, 2025.Section d4: udi number: (b)(4).Section d6a: if implanted, give date: (b)(6) 2023.Section d6b: if explanted; give date: n/a (not applicable).The lens remains implanted.Section h4: device manufacture date: nov 20, 2022.Device evaluation: the customer provided a photo and a visual inspection of the photo revealed a stress mark on the cartridge leading to the cartridge tip.The stress mark identified was observed to be within specification because no lens was stuck inside the cartridge, and no cartridge or cartridge tip crack was identified.The cartridge tip was also slightly deformed.No photo of the complaint lens was received; therefore, the complaint issue of lens damage could not be confirmed.No further product evaluation could be performed.The complaint issue " cartridge tip cracked/damaged was identified during product evaluation; however, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.The other observed issue found during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Conclusion: based on the complaint investigation results, the product was released within specifications and a relationship between the device and the reported incident could not be determined.As a result of the investigation there is no product quality deficiency, and the reported issue could not be identified.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: 16487166
• Report Number: 3012236936-2023-00582
• Device Sequence Number: 5899897
• Product Code: HQL
• UDI-Device Identifier: 05050474635951
• UDI-Public: (01)05050474635951(17)251120
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 04/29/2023

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: 11/20/2025
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000135
• 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: 02/08/2023
• Supplement Date Received by Manufacturer: 04/05/2023
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 04/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2022
• 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 Sex: Unknown