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

Model Number	DIB00
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cartridge for the preloaded johnson and johnson(jnj) intraocular lens (iol) cracked at the tip.The issue was noticed during implantation.The iol did not contact the eye only the cartridge tip.Reportedly, there was no capsule tear, vitrectomy, incision enlargement or sutures.No further information was provided.
Additional Manufacturer Narrative
Section a, patient information, section d6a, if implanted, give date: not applicable.There's no indication the lens was implanted.Section d6b, if explanted, give date: not applicable.There's no indication the lens was implanted.Hence, not explanted.Section h3-other (81): 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.An attempt was made to obtain the missing information.However, the customer said it's not available.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: aug 3, 2023.Section h3: evaluated by manufacturer: yes.Device evaluation: the complaint lens, handpiece, handpiece tray, and folding carton were received.The complaint lens was received overridden and partially stuck in the handpiece cartridge and was also observed to be damaged, torn, and with haptic damage.Cartridge tip damage and cartridge crack was also observed.Plunger rod tip damage was also observed consistent with excessive force during lens advancement.No further handpiece defects and assembly issues were observed before and after disassembling the handpiece for evaluation.Trace amounts of viscoelastic residue was observed which suggests an inadequate amount of ovd was used during loading and insertion which may have contributed to the complaint issue.The stuck lens was not removed from the cartridge to avoid introducing additional damage unrelated to the return condition of the lens.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: 17187709
• Report Number: 3012236936-2023-01576
• Device Sequence Number: 7263194
• Product Code: HQL
• UDI-Device Identifier: 05050474731677
• UDI-Public: (01)05050474731677(17)250321
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 09/07/2023

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: 03/21/2025
• Device Model Number: DIB00
• Device Catalogue Number: DIB00U0160
• 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: 06/20/2023
• Supplement Date Received by Manufacturer: 09/01/2023
• Initial Report FDA Received Date: 06/22/2023
• Supplement Report FDA Received Date: 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2022
• 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