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

Model Number	DCB00
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when inserting the intraocular lens ( iol), the trailing haptic was stuck in the cartridge.The surgeon tried to nudge the haptic loose with a sinskey hook, followed by a micrograsper, but the tip of the haptic remained stuck and actually broke off, with the broken bit remaining in the tip of the cartridge.The iol was sitting in good position and the surgeon opted to leave it implanted as is, at the time of surgery.The cartridge was fully filled with balanced saline solution at the time for implantation.Through follow up it was learned that the surgeon decided to leave the iol as he used miostat to constrict the pupil and close the incision in the usual manner as part of standard of care.There was a five minute delay.It is unknown if the patient will require an explant or not.The patient outcome was reported as unknown.No further information was provided.
Additional Manufacturer Narrative
Section a2, a4, a5: unknown/asked but unavailable (asku).Section d6b: if explanted; give date: n/a (not applicable).The lens remains implanted.Section e1: telephone number (b)(6).Section h3-other (81): 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.Attempts have been made to obtain missing information.However, the account did not have the information.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional info: section d9: device available for evaluation? yes.Section d9: returned to manufacturer on: (b)(6) 2023.Section h3: device evaluated by manufacturer ¿ yes.Device evaluation: the folding carton, labels and suspect handpiece were received.No iol was received.The suspect handpiece was received with the plunger rod fully advanced, and the lens haptic was detached and stuck in the cartridge.No assembly issues were identified before and after disassembly.An insufficient amount of ovd was observed, and could potentially contribute to the complaint event reported.The "trailing haptic not folded" was not confirmed as the iol was not returned.The complaint issue "haptic detached" 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.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be confirmed.All pertinent information available to johnson and 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: 17056506
• Report Number: 3012236936-2023-01372
• Device Sequence Number: 12475832
• Product Code: HQL
• UDI-Device Identifier: 05050474636033
• UDI-Public: (01)05050474636033(17)251112
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2023

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: 11/12/2025
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000175
• 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: 05/09/2023
• Supplement Date Received by Manufacturer: 07/08/2023
• Initial Report FDA Received Date: 06/02/2023
• Supplement Report FDA Received Date: 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2022
• 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