MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. LAMINAR; UNIT, PHACOFRAGMENTATION

Model Number	OPOCR3020R
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a2, a4 and a5: per regulation eu 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Section b3 - date of event: between (b)(6) 2024.Exact date unknown, as information was requested but not provided.Section d6a - implant date: not applicable.Phaco tips are not an implantable device.Section d6b - explant date: not applicable.Phaco tips are not an implantable device; therefore, not explanted.Section e1 - telephone number: (b)(6).Section h3 - the phaco tip is not returning for evaluation.Therefore, a failure analysis of the complaint device could not 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 and possible product return and evaluation, if there is any further relevant information a supplemental medwatch will be filed.Attempts have been made to obtain missing information.However, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that five phaco tips were blocked, with the number of sterilizations ranging from a maximum of 10 times (5/6/6/4/10).It was also reported that there was patient contact.Through follow-ups, we learned that the events occurred between july 1 and july 12, 2024.The exact dates of the events are unknown.The phaco tips were inside the eye.The treatments were interrupted because the phaco tips needed to be changed.This did not result in any surgical interventions.The materials were discarded.No further details were provided.This report pertains to one of the phaco tips.Four separate reports will be submitted for the other phaco tips.

• Brand Name: LAMINAR
• Common Device Name: UNIT, PHACOFRAGMENTATION
• 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: 19920988
• Report Number: 3012236936-2024-000209
• Device Sequence Number: 7244775
• Product Code: HQC
• UDI-Device Identifier: 05050474520981
• UDI-Public: (01)05050474520981(17)260208(10)5495511
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K844373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/06/2024

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: 02/08/2026
• Device Model Number: OPOCR3020R
• Device Catalogue Number: OPOCR3020R
• Device Lot Number: 5495511
• 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: 07/15/2024
• Initial Report FDA Received Date: 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/08/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose