FDA Adverse Event
Malfunction
Summary report: N
ALLEGRETTO WAVE
MDR report key: 2161063
·
Received June 16, 2011
Report
- Report Number
- 3003288808-2011-00157
- Event Type
- Malfunction
- Date Received
- June 16, 2011
- Date of Event
- April 1, 2009
- Report Date
- April 1, 2009
- Manufacturer
- WAVELIGHT GMBH
- Product Code
- LZS
- PMA / PMN Number
- P030008/PO
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DURING THE ONSITE INVESTIGATION, THE SVC TECH REPLACED THE MONITOR AND THE BNC CABLE. ROOT CAUSE WAS IDENTIFIED AS A FAULTY MONITOR. (B)(4). THIS REPORT WAS MAILED TO FDA ON: (B)(4) 211. (B)(4).
Description of Event or Problem · 1
A PHYSICIAN REPORTS BOTH CHANNELS OF THE EYETRACKER MONITOR FAILED BETWEEN TWO EYES. AFTER SWITCHING THE LASER OFF AND REBOOTING, THE NORMAL EYETRACKER IMAGE APPEARED. PT'S SURGERY WAS RESCHEDULED. NO PT HARM WAS REPORTED AND NO ADD'L INFO HAS BEEN PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALLEGRETTO WAVE | OPHTHALMIC EXCIMER LASER SYSTEM | LZS | WAVELIGHT GMBH | 8065990600 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |