FDA Adverse Event Injury Summary report: N

TECHNOLAS EXCIMER WORKSTATION

MDR report key: 2274701 · Received September 21, 2011

Report

Report Number: 3007606649-2011-00002
Event Type: Injury
Date Received: September 21, 2011
Date of Event: February 20, 2009
Report Date: April 26, 2010
Manufacturer: TECHNOLAS PERFECT VISION GMBH, HEADQUARTERS
Product Code: LZS
PMA / PMN Number: P990027
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

THE REPORTER DID NOT PROVIDE CONTACT INFO FOR F/U AND THE DEVICE SERIAL NUMBER WAS NOT PROVIDED. UNABLE TO PERFORM A DEVICE EVAL OR DRAW CONCLUSIONS REGARDING ROOT CAUSE DUE TO LACK OF INFO. THE LIKELIHOOD THAT THE EXCIMER LASER CAUSED OR CONTRIBUTED TO THE CRANIAL (TROCHLEAR) NERVE DAMAGE IS REMOTE SINCE THE EXCIMER LASER ONLY INTERACTS WITH THE FIRST FEW MICRONS OF THE CENTRAL CORNEAL TISSUE. COMPLAINTS OF DOUBLE VISION AND LOSS OF DEPTH PERCEPTION ARE KNOWN RISKS OF LASIK SURGERY AND ARE IDENTIFIED IN THE DEVICE LABELING. (B)(4).

Description of Event or Problem · 1

(B)(4). A PT REPORTED UNDERGOING PRK ENHANCEMENT SURGERY ON THE LEFT EYE IN 2009 TO CORRECT PRE-EXISTING SURGICALLY INDUCED MONOVISION. POSTOPERATIVELY, THE PT REPORTS EXPERIENCING PERMANENT PAIN THAT HAS BEEN DIAGNOSED BY A NEURO-OPHTHALMOLOGIST AS DAMAGE TO THE 4TH CRANIAL NERVE (TROCHLEAR NERVE). IN ADDITION, THE PT REPORTS EXPERIENCING DOUBLE VISION, LOSS OF DEPTH PERCEPTION, INCREASED DIFFICULTIES CONCENTRATING, MEMORY LOSS, AND DEPRESSION. THE PT HAS BEEN PRESCRIBED GABAPENTIN (2700 MG). THE RELATIONSHIP BETWEEN THE EVENT AND THE DEVICE IS UNK.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	TECHNOLAS EXCIMER WORKSTATION	TECHNOLAS 217Z ZYOPTIX SYSTEM	LZS	TECHNOLAS PERFECT VISION GMBH, HEADQUARTERS

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention\| S