FDA Adverse Event Injury Summary report: N

INTRALASE FS2

MDR report key: 2973164 · Received February 21, 2013

Report

Report Number: 3006695864-2013-00057
Event Type: Injury
Date Received: February 21, 2013
Date of Event: January 25, 2013
Report Date: January 25, 2013
Manufacturer: ABBOTT MEDICAL OPTICS
Product Code: HNO
PMA / PMN Number: K060372
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

CONCLUSION - THE EQUIPMENT WAS NOT EVALUATED AFTER THE TREATMENT DATE WHICH OCCURRED ON (B)(6) 2013 DUE TO THE FACT ABBOTT MEDICAL OPTICS (AMO) BECAME AWARE ON (B)(6) 2013 OF THE PATIENT'S LOSS OF BCVA AND HAZE. THE CONDITION OF THE SYSTEM (SINCE THE TIME OF THE EVENT) WILL MAKE THE EVALUATION IMPOSSIBLE. THE CLINIC REPORTED THIS EVENT ONLY AND DID NOT REQUEST FIELD SERVICE OR CLINICAL SUPPORT.

Additional Manufacturer Narrative · 1

(B)(4). DATE RECEIVED BY MANUFACTURER - 01/25/2013. (B)(4): PLACEHOLDER.

Description of Event or Problem · 1

CUSTOMER REPORTED A CORNEAL ABRASION LEFT EYE (OS) DURING TREATMENT SECONDARY TO FLAP LIFT COMPLICATIONS ON (B)(6) 2013. UNCORRECTED VISUAL ACUITY (UCVA) ON (B)(6) 2013 WAS 20/25-2 RIGHT EYE (OD) AND 20/100 OS. ON (B)(6) 2013, PATIENT FOLLOW UP INFORMATION WAS RECEIVED. THIS CASE HAS NOT REQUIRED SURGICAL INTERVENTION. PRE-OP BEST CORRECTED VISUAL ACUITY (BCVA) WAS 20/20 OD, 20/20 OS AND 20/20 BOTH EYES (OU). POST-OP BCVA ON (B)(6) 2013 WAS 20/30 OD, 20/50-1 OS AND 20/25-1 OU. THE ABRASION WAS HEALED BY THE 1 WEEK POST OP. THE PATIENT IS CURRENTLY DEALING WITH SOME HAZE. THE CUSTOMER PRESCRIBED A STEROID TAPER.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
76924	INTRALASE FS2	FEMTOSECOND LASER	HNO	ABBOTT MEDICAL OPTICS	20005D

Patients

Seq	Age	Sex	Outcome	Treatment
1	44 YR		Other