FDA Adverse Event Injury Summary report: N

ALLEGRETTO WAVE EYE-Q EXCIMER LASER

MDR report key: 5002199 · Received August 13, 2015

Report

Report Number: 3003288808-2015-06142
Event Type: Injury
Date Received: August 13, 2015
Date of Event: July 20, 2015
Report Date: August 13, 2015
Manufacturer: WAVELIGHT GMBH
Product Code: LZS
PMA / PMN Number: P020050
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: IN, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

EVALUATION SUMMARY: THE DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE WAS REVIEWED. THE ASSOCIATED DEVICE WAS RELEASED BASED ON COMPANY ACCEPTANCE CRITERIA. TECHNICAL ROOT CAUSE COULD NOT BE DETERMINED AS THE SYSTEM WAS PERFORMING WITHIN SPECIFICATIONS AND AS INTENDED. THE CONTRIBUTING FACTORS COULD BE STERILIZATION OF INSTRUMENTS, SURGICAL TECHNIQUES, PRE AND POST-OPERATIVE MEDICATIONS. NO UDI REQUIRED DUE TO THIS DEVICE WAS OUT OF PRODUCTION PRIOR TO THE SEPTEMBER 24, 2014 UDI REGULATION DATE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

Description of Event or Problem · 1

AN OPTOMETRIST REPORTED THAT TWO DAYS FOLLOWING BILATERAL LASIK SURGERY, THE PATIENT PRESENTED WITH GRADED 2, DIFFUSED LAMELLAR KERATITIS (DLK) IN THE RIGHT EYE. THE PATIENT REPORTED EXPERIENCING HAZY VISION AND LIGHT SENSITIVITY. THE TOPICAL STEROID DROPS WERE INCREASED TO TREAT THE EVENT. IN A FOLLOW UP, THE OPTOMETRIST REPORTED THAT THE EVENT HAD RESOLVED WITHIN ONE DAY. THERE ARE TWO RELATED REPORTS FOR THIS PATIENT. THIS REPORT ADDRESSES THE PATIENT'S RIGHT EYE, AND ANOTHER MANUFACTURER REPORT WILL BE FILED FOR THE FELLOW EYE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
534232	ALLEGRETTO WAVE EYE-Q EXCIMER LASER	OPHTHALMIC EXCIMER LASER SYSTEM	LZS	WAVELIGHT GMBH	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	35 YR		Required Intervention