MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. INTRALASE TECHNOLOGY PI; POWERED LASER SURGICAL INSTRUMENT

Model Number	0155-1825
Medical Device Problem Codes	Computer Software Problem (1112); Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a2, a3, a4 and a5: unknown/ not provided.Section d6a: if implanted, give date: unknown/ not provided.Section d6b: if explanted, give date: unknown/ 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 cannot 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, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported by the customer that during the use of the elita® two-piece patient interface system on (b)(6) 2025, the pi (patient interface) scan failed after the cone was installed.The nurse checked the cone and found that the inner cone, the contact lens, had water/oil stains.They suspect there was a leak between the contact lens and the silicone sealing junction in the first pi cone, and water/oil stains were left on the laser head, leading to contamination of the pi cone.No further information available.

• Brand Name: INTRALASE TECHNOLOGY PI
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• 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: 22923276
• Report Number: 3012236936-2025-000229
• Device Sequence Number: 15743802
• Product Code: GEX
• UDI-Device Identifier: 05050474655690
• UDI-Public: (01)05050474655690(17)261209(10)25142243
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K060372
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/29/2025

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: 0155-1825
• Device Catalogue Number: 0155-1825
• Device Lot Number: 25142243
• 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: 08/02/2025
• Initial Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/09/2024
• 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