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

Model Number 20005K

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/10/2017

Event Type  Injury  

Manufacturer Narrative

Field service specialist visited account and check system and no problem was encountered.Reseated pcbs and cables.Z calibration, checked gel thickness.No further problems encountered.Present during initial treatments.All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that part way through bed cut the raster pattern became white then stopped with error 209, which kept occurring.System was powered down and restarted.It was reported that test treatments performed ok.Patient outcome is unknown.Surgeon had no qualms that with no sidecut there was no problem and decided to treat with lasek and refractive surgery.

Manufacturer Narrative

Device evaluation: a review of the records related to this equipment that included labeling, manuals, trending, and risk documentation reviews for this equipment were performed.The trend review shows that there is not 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.Based on the investigation an electrical problem was found.All pertinent information available to abbott medical optics 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 ; 7142478567
• MDR Report Key: 6465537
• MDR Text Key: 72057823
• Report Number: 3006695864-2017-00219
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 07/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2017
• 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?: No
• Date Manufacturer Received: 07/05/2017
• 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): Required Intervention