MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. UNK_UNFOLDER HANDPIECE; LENS, GUIDE, INTRAOCULAR

Model Number	UNK-UNFOLDER HANDPIECE
Medical Device Problem Codes	Break (1069); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the zcb00 intraocular lens (iol) had a broken haptic.Account also mentioned possible loading error.Through follow-up, additional information was received clarifying possible loading error stating we think it was a bent lens inserter.The cartridge had patient contact.There was no incision enlargement, no serious patient injury, no suture(s), and no vitrectomy.The same procedure was completed using back-up lens with the same model and diopter size.Patient outcome post-procedure was reported as: good.Iol is not available for return as it was discarded.Additional information was acquired through follow-up confirming the lens inserter was bent and the instrument was repaired.No further information is available.
Additional Manufacturer Narrative
Date implanted: not applicable, as the handpiece is not an implantable device.Date explanted: not applicable, as the handpiece is not an implantable device.The device was not returned for analysis.Therefore, a visual analysis of the complaint device cannot be completed.Device lot number is not available; therefore, no further investigation can be performed.If there is any further relevant information received, a supplemental medwatch report will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: UNK_UNFOLDER HANDPIECE
• Common Device Name: LENS, GUIDE, INTRAOCULAR
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 31 technology drive; irvine CA 92618
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 16075096
• Report Number: 3012236936-2022-03217
• Device Sequence Number: 6187243
• Product Code: KYB
• UDI-Device Identifier: 05050474548657
• UDI-Public: (01)(10)UNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K961242
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/29/2022

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 Model Number: UNK-UNFOLDER HANDPIECE
• Device Catalogue Number: UNK-UNFOLDER HANDPIECE
• Device Lot Number: UNKNOWN
• 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: 12/08/2022
• Initial Report FDA Received Date: 12/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ZCB00 LENS, SN: (B)(4)
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Race: White