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

Model Number 20003D

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 02/04/2014

Event Type  Injury  

Manufacturer Narrative

Corrected data: in the initial mdr the following sections were not populated: patient identifier: (b)(6); age at time of event: (b)(6); date of birth: (b)(6) 1993; sex: male.All pertinent information available to abbott medical optics has been submitted.Placeholder.

Event Description

The clinic reported that a laser vision correction patient developed corneal ectasia in left eye, after lasik treatment that was done for both eyes in 2011.The patient stated that he started experiencing blurry vision and astigmatism.No loss of best corrected visual acuity (bcva) reported.

Manufacturer Narrative

(b)(4).The clinic is reporting this adverse event only and did not request or require field service or clinical support.Patient had surgery on his (b)(6) birthday based on the initial report of the event.It has to be mentioned that lasik surgery is not recommended for patients with refractive instability and that are in their early 20s or younger.All pertinent information available to abbott medical optics has been submitted.Placeholder.

Manufacturer Narrative

Device available for evaluation: yes.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: 3653902
• MDR Text Key: 13125835
• Report Number: 3006695864-2014-00125
• Device Sequence Number: 1
• Product Code: HNO
• 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 Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 20003D
• Device Catalogue Number: 20003D
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2007
• 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: VISX 5873
• Patient Outcome(s): Other
• Patient Age: 20 YR