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

Model Number 20003D

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Blurred Vision (2137); Visual Impairment (2138); No Code Available (3191)

Event Date 03/01/2015

Event Type  Injury  

Event Description

The surgery center reported that a laser vision correction patient that was treated for hyperopic astigmatism and under corrected for near vision on the left eye was presented with macrostriae, a dislodged flap and epithelial ingrowth in the exposed stromal bed on the left eye at 1 day post op.The patient¿s chief complaint at the one day post op visit was blurry and loss of best corrected visual acuity.In addition, the patient stated the left eye felt the same as her right eye that was treated years ago.Best correct visual acuity for left eye was distance 20/200, pre-op 20/20.Although, the surgery reported at one day post op, the event was lasting and disabling, significantly interfering with daily activities, at a later time on the same date of evaluation, the event was not lasting and disabling, significantly interfering with the daily activities.A flap lift/rinse, debridement and repositioning was performed and topical steroid dosage was increased.In addition, the patient at the one day post op visit requested a monovision treatment.The monovision was not requested by patient initially.The monovision enhancement treatment will be scheduled after 3 months or more.The surgery center indicated the laser system had in recent weeks 3 errors for (b)(4) displaced and 3 aborted patient interface (pi) docks then rebooted laser system to repeat the docking the pi, hence, the account was able to complete treatments.A field service specialist visited the site.

Manufacturer Narrative

(b)(4).The laser system was examined and tested at the customer location by an amo field service specialist (fss) for the report of the (b)(4) out of position error.The fss performed a field service checklist.The fss performed all calibrations and measured the gel multiple times as part of the field service checklist.The system was verified for all modes of operations.The system met amo specifications.All pertinent information available to abbott medical optics has been submitted.Placeholder.

• 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: 4633658
• MDR Text Key: 20785763
• Report Number: 3006695864-2015-00094
• Device Sequence Number: 1
• Product Code: HNO
• Combination Product (y/n): N
• PMA/PMN Number: K060372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 20003D
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2007
• 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
• Treatment: WAVELIGHT SERIAL NO.(B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR