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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that metal particles were found in the patient's eye during a medical examination following surgery.Through follow-up, we learned, that an anterior chamber lavage was performed on (b)(6) 2026.No further information was provided.
Additional Manufacturer Narrative
Section d6a section d6b section e1 - first/given name: unknown, as information was requested but not provided.Section e1 - last name: unknown, as information was requested but not provided.Section e1 - email address: unknown, as information was requested but not provided.Section e1 - telephone number: (b)(6).Section h3 - the device was not returned for evaluation.Therefore, a failure analysis of the complaint device could not be completed.A review of the device history record and complaint trending 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.

• 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: 50210968
• Report Number: 3012236936-2026-000239
• Device Sequence Number: 13264203
• Product Code: HQC
• UDI-Device Identifier: 05050474500365
• UDI-Public: (01)05050474500365(17)281024(10)5934934
• 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): 08/11/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: OPOR3020L
• Device Catalogue Number: OPOR3020L
• Device Lot Number: 5934934
• 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: 07/17/2026
• Initial Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/24/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown