FDA Adverse Event Injury Summary report: N

ALLEGRETTO WAVE EYE-Q

MDR report key: 1972388 · Received January 20, 2011

Report

Report Number: 3003288808-2011-00007
Event Type: Injury
Date Received: January 20, 2011
Date of Event: December 2, 2010
Report Date: December 21, 2010
Manufacturer: WAVELIGHT GMBH
Product Code: LZS
PMA / PMN Number: P030008
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: WI, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

Description of Event or Problem · 1

OPTOMETRIST REPORTS A PATIENT OUTCOME OF OVERCORRECTION AND INDUCED ASTIGMATISM, FOLLOWING LASIK SURGERY. THE MDR WILL ADDRESS THE PATIENT'S RIGHT EYE. LEFT EYE OF THE SAME PATIENT WILL BE REPORTED UNDER MANUFACTURER REPORT # 3003288808-2011-00008. PATIENT RECORDS WERE RECEIVED, SHOWING PRE OPERATIVE DATA AND POST OPERATIVE VISITS AT 1 DAY, 8 DAYS AND 14 DAYS. RECORDS SHOW FINDING OF EDEMA ON ALL 3 POST OP VISITS, AND A 1 LINE LOSS OF BCVA AT DAY 14 POST OP. AN INVESTIGATION INTO THE POSSIBLE CAUSES, PRODUCT AND NON PRODUCT FACTORS, IS BEING CONDUCTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ALLEGRETTO WAVE EYE-Q	OPHTHALMIC EXCIMER LASER SYSTEM	LZS	WAVELIGHT GMBH	8065990601	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	50 YR		Other