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

Model Number	OPOCR3020L
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported a hard plastic shreds coming from the yellow phaco/irrigation aspiration sleeve, laminar flow phaco tip.The the plastic shred entered a patient's eye, which was removed without issue.There was no harm to the patient, and the surgery concluded uneventfully.
Additional Manufacturer Narrative
Section a2, a3a., a3b., a4 and a5: unknown/ not provided.Section d6a: if implanted, give date: not applicable, as the phaco tip is not implantable.Device.Section d6b: if explanted, give date: not applicable, as the phaco tip is not implantable.Device.Section e1: telephone number, (b)(6).Section h3: the device was not returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of records including device history and complaint trending 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 missing information; however, customer did not have no additional information.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.
Additional Manufacturer Narrative
Section h4: device manufacture date: sep 3, 2024.Device evaluation: a photo analysis of an image provided by customer shows a phaco sleeve beside an ungloved finger tip with a piece of foreign material on it.It cannot be confirmed that the observed foreign material came from the phaco sleeve or tip from photo analysis.At the time of the investigation, product was not available for evaluation, therefore no testing could be performed.If product is received and product evaluation is required, this investigation record will be reopened to document product evaluation results.No related deviation during the manufacturing process of the reported lot#.All devices meet material, assembly, and performance specifications at the time of product release.Based on the information obtained, it cannot be confirmed that the observed foreign material came from the phaco sleeve or tip from photo analysis.Therefore, product malfunction and deficiency cannot be confirmed.Johnson & johnson surgical vision will continue to monitor this type of complaints.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.

• 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: 21911600
• Report Number: 3012236936-2025-000116
• Device Sequence Number: 7238183
• Product Code: HQC
• UDI-Device Identifier: 05050474500273
• UDI-Public: (01)05050474500273(17)270903(10)5757863
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K121721
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2025

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: OPOCR3020L
• Device Catalogue Number: OPOCR3020L
• Device Lot Number: 5757863
• 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: 04/01/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/03/2024
• 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