MAUDE Adverse Event Report: Johnson & Johnson Surgical Vision, Inc. LAMINAR; Unit, Phacofragmentation

Model Number	OPOR3020L
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	08/27/2026
Type of Reportable Event	Malfunction

• 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 ; +1(714)247-8552
• MDR Report Key: 50903465
• Report Number: 3012236936-2026-000283
• Device Sequence Number: 18819402
• Product Code: HQC
• UDI-Device Identifier: 05050474500365
• UDI-Public: (01)05050474500365(17)280206(10)5837486
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: OPOR3020L
• Device Catalogue Number: OPOR3020L
• Device Lot Number: 5837486
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/06/2025
• 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: Unknown