FDA Adverse Event Injury Summary report: N

CEE ON LENS

MDR report key: 160162 · Received March 27, 1998

Report

Report Number
57701-1998-00007
Event Type
Injury
Date Received
March 27, 1998
Date of Event
September 23, 1997
Report Date
March 24, 1998
Manufacturer
PHARMACIA BV PRODUCTION
Product Code
HQL
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
KY, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

THIS REPORT WAS REC'D FROM AN OPHTHALMOLOGIST OF A REFRACTIVE ERROR OF -6 DIOPTERS SPHERICAL EQUIVALENT, WITH MODEL 811A, 23 (D), INTRAOCULAR LENS. SECONDARY SURGERY FOR EXPLANT AND REPLACEMENT OF ANOTHER IOL, DIOPTER 18 WAS NECESSARY. THIS IOL WAS IMPLANTED ON SEPT. 23, 1997. AFTER IMPLANT, IT WAS FOUND THAT A REFRACTIVE ERROR OF -6 DIOPTERS SPHERICAL EQUIVALENT WAS NOTED. HE INDICATED THAT SHE WAS DIFFICULT TO MEASURE. SHE HAD A VERY STEEP CORNEA WITH KERATOMETRIC MEASUREMENTS OF APPROXIMATELY 50 DIOPTERS POWER, BOTH EYES. HER VISUAL ACUITY IN THE RIGHT EYE PRIOR TO SURGERY WAS HAND MOTION SECONDARY TO HER MATURE CATARACT. THE AXIAL LENGTHS WERE 21.12MM (RIGHT EYE) AND 21.18MM (LEFT EYE). FROM THE SRK II REGRESSION FORMULA AND APPROXIMATELY 21.34 DIOPTER LENS WAS RECOMMENDED. AS MOST SHORT EYES AND THIS ONE BEING 21.12 MM IN AXIAL LENGTH, THIS WAS CONSIDERED A SHORT EYE, GENERALLY AT THE GREATER THAN 2 STANDARD DEVIATIONS FROM THE MEAN ON THE BELL CURVE, SOME ADDITIONAL "FUDGING" WAS MADE. IT WAS HIS EXPERIENCE AS WELL AS THROUGH THE LITERATURE, THAT INCREASING THE INTRAOCULAR LENS POWER SLIGHTLY WAS PREFERABLE TO OBTAIN CLOSER TO AN EMMETROPIC STATE AND WHEN THE EYE IS OF GREATER THAN NORMAL AXIAL LENGTH, A LESSER DIOPTER POWER THAN ACTUALLY WHAT IS CALLED FOR ON THE CALCULATIONS IS NECESSARY. THE IMPLANT WAS EXCHANGED (OCT 8, 1997) EMPIRICALLY WITH THE REFRACTIVE ERROR AND AN 811A/18 DIOPTER LENS WAS PLACED. THIS RESULTED IN A MUCH MORE COMPATIBLE REFRACTIVE ERROR, THOUGH THE PT SAYING "THE VISION IS BETTER THAN BEFORE". THE PT WAS REFERRED TO AN OPTOMETRIST FOR HER FINAL GLASSES PRESCRIPTION. THE REFRACTION WAS -150 +75 AT 75 DEGREES WITH A CORRECTION 20/40.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 CEE ON LENS Implant INTRAOCULAR LENS HQL PHARMACIA BV PRODUCTION 811A NI

Patients

Seq Age Sex Outcome Treatment
1 85 YR Required Intervention