TERRY-SCHANZLIN ASTIGMATOME

Description of Event or Problem

A PATIENT WHO, ACCORDING TO THE ASTIGMATOME NOMAGRAM, REQUIRED TWO 45 DEGREE ARCUATE INCISIONS USING THE 8 MM OPTICAL ZONE. PRE-OP CORNEAL TOPOGRAPHY SHOWED CENTRAL PACHYMETRY OF ABOUT 550 MICRONS AND MID-PERIPHERAL CORNEAL THICKNESSES OF 580+ MICRONS, SO A 550 MICRON DOUBLE BLADE WAS CHOSEN. THE ASTIGMATOME WAS EMPLOYED IN THE USUAL FASHION AT THE BEGINNING OF THE CASE PRIOR TO THE PERFORMANCE OF THE PHAKO/IOL PORTION OF THE PROCEDURE USING A REZOOM LENS, AND RESULTING IN TWO FULL-THICKNESS 45 DEGREE INCISIONS. EACH INCISION REQUIRED SUTURING WITH A FIGURE-EIGHT 10-0 NYLON SUTURE.

Additional Manufacturer Narrative

OASIS MEDICAL IS COMMUNICATING WITH THE CUSTOMER TO HAVE THE CUSTOMER RETURN THE PRODUCT IN QUESTION, AND OASIS MEDICAL WILL EVALUATE AND SUBMIT A EVALUATION SUMMARY WHEN IT IS AVAILABLE. AS OF THE DATE OF THIS INITIAL MDR, THE PRODUCT HAS NOT VEEN RECEIVED. VARIOUS COMMUNICATIONS WITH THE CUSTOMER HAVE NOT BEEN ABLE TO OBTAIN THE LOT NUMBER OR DETAILED DESCRIPTION OF FOLLOW-UP EVENTS.