MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC INTRALASE FS2; FEMTOSECOND LASER

Model Number 20005K

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Code Available (3191)

Event Date 04/11/2018

Event Type  Injury  

Manufacturer Narrative

(b)(6).Field service specialist visited the account and could not reproduce the fault.Multiple start-up & shutdowns performed with procedures in between.No repeat of the error.Multiple tests & no error found although there was evidence in the error log could not get the fault to repeat.A review of records related to the device including labeling, complaint trending, and risk documentation will be performed.Upon completion of this review, if there is any further relevant information obtained, a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.

Event Description

It was reported that while laser was firing during the creation of a flap in the patient¿s right eye the system gave a 211 galvo error message half way through the bed cut (raster).Patient was re-scheduled.Patient was given routine post-op drops which include antibiotics, anti-inflammatory and lubricating drops.No bandage contact lens.Patient attended 24 hour post operative appointment, all was okay and the optometrist commented that the flap could not be seen, no best corrected visual acuity available.

• Brand Name: INTRALASE FS2
• Type of Device: FEMTOSECOND LASER
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC; santa ana CA
• Manufacturer (Section G): JOHNSON & JOHNSON SURGICAL VISION, INC; 510 cottonwood drive; milpitas CA 95035
• Manufacturer Contact: valerie sedzicki ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478567
• MDR Report Key: 7501370
• MDR Text Key: 107820658
• Report Number: 3006695864-2018-01034
• Device Sequence Number: 1
• Product Code: HNO
• UDI-Device Identifier: 05050474540231
• UDI-Public: (01)05050474540231
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K060372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 20005K
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 29 YR