MalfunctionHMT
CATARACT CUSTOM DRAPE PACK
Received Jun 18, 2014 · Event occurred Nov 4, 2013
Report 3893439 · MDR key 3893439
Device
Generic name
Drape, Surgical
Manufacturer
Alcon Laboratories, IncModel number
*Catalog number
*
Lot number
1503113H
Product problems
- Device Contamination with Chemical or Other Material
Patient
71 YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
CATARACT CUSTOM PACK CONTAINED A FOREIGN SPECK OF SOME MATERIAL. DISCOVERED DURING CASE SET-UP. NEW PACK OBTAINED. NO PATIENT HARM.