MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS INTRALASE FS2; FEMTOSECOND LASER

Model Number 20003

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Code Available (3191)

Event Date 01/12/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Field service specialist visited the account and confirmed on arrival energy subsystem error during surgery, customer reboot did not resolve error.He checked and adjusted diode driver current, temp setting and hv to pockel setting.He replaced the ac to dc switcher and diode driver board as the error message was at startup on 4 attempts.Six (6) startups after switcher and diode driver board replacement started up normally with no error messages.Performed pm, system meets (b)(4) spec.All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that during a procedure with 6 seconds left on the right (od) eye, the system stopped lasing.Surgeon converted patient to photorefractive keratectomy (prk) on right (od) eye.No patient injury has been reported.

Manufacturer Narrative

A review of the records related to the device that included labeling, manuals, trending, and risk documentation was performed.The trend review shows that there is no significant change over historical complaint limits and no recognizable adverse trend.The risks and mitigations associated with the complaint issue are identified in existing risk documents and no new risks were identified as part of this investigation.There was no product deficiency identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: INTRALASE FS2
• Type of Device: FEMTOSECOND LASER
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• Manufacturer (Section G): ABBOTT MEDICAL OPTICS INC.; 510 cottonwood drive; milpitas CA 95035
• Manufacturer Contact: valerie sedzicki ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478497
• MDR Report Key: 7260365
• MDR Text Key: 99601442
• Report Number: 3006695864-2018-00244
• Device Sequence Number: 1
• Product Code: HNO
• UDI-Public: (01)
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 20003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2004
• 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): Required Intervention