WAVELIGHT EX500 EXCIMER LASER

Additional Manufacturer Narrative

H.3., H.6.: 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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

Description of Event or Problem

A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE SURGEON CREATED A FLAP USING A MICROKERATOME, THEN LIFTED AND REPOSITIONED THE FLAP AFTER TEN DAYS LATER DUE TO THIS CORNEA STRIAE WERE NOTED. POSTOPERATIVELY, THE PATIENT HAD RESIDUAL CYLINDRICAL REFRACTIVE ERROR WITH THE MANIFEST REFRACTIVE SPHERICAL EQUIVALENT WAS GREATER THAN ONE DIOPTER AND WITH A LOSS OF MORE THAN TWO LINES OF BEST-CORRECTED VISUAL ACUITY. AFTER POST OPERATIVE EXAMINATION, THE PREVIOUSLY NOTED CORNEA STRIAE HAD RESOLVED COMPLETELY, WITH NO REMAINING ISSUES. A RETREATMENT ASSESSMENT FOR THE RIGHT HAS BEEN SCHEDULED AFTER A MONTH. THE OUTCOME IN THE LEFT EYE WAS REPORTED AS PERFECT, WITH NO COMPLICATIONS NOTED. THE PATIENT IS SATISFIED WITH THE LEFT EYE, AS THE SURGEON INTENTIONALLY CREATED A SLIGHT MONOVISION EFFECT.