FDA Adverse Event Injury Summary report: N

TORIC LENS

MDR report key: 21168271 · Received January 16, 2025

Report

Report Number
MW5164795
Event Type
Injury
Date Received
January 16, 2025
Date of Event
December 13, 2024
Report Date
January 10, 2025
Manufacturer
UNK
Product Code
MJP
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
OR, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

THIS IS A CORRECTION TO THE REPORT I SUBMITTED ON JANUARY 3, 2025. THE SUSPECT DRUG WAS NOT MOXIFLOXACIN, ADMINISTERED INTRACAMERALLY. I OBTAINED THE SURGICAL NOTES FROM THE OPHTHALMOLOGIST WHO DID THE SURGERY, DR. (B)(6), MD. INSTEAD, THE DRUG WAS VANCOMYCIN 0.3 ML, ADMINISTERED SUBCONJUNCTIVALLY. TWO ADDITIONAL POINTS OF FACT, WHICH I NEGLECTED TO INCLUDE IN MY REPORT OF JANUARY 3, 2025, WAS THAT SIX DAYS AFTER THE SUTURE PLACEMENT SURGERY, PACHYMETRY WAS DONE ON MY OPERATED RIGHT EYE WITH A HANDHELD DEVICE, AND MY CORNEAL THICKNESS WAS MEASURED TO BE 551 MICROMETERS. MY BASELINE CORNEAL THICKNESS IS 460 - 470 MICROMETERS, SO CORNEAL EDEMA WAS PRESENT FOLLOWING THE STITCH SURGERY. ADDITIONALLY, AND ALSO SIX DAYS AFTER THE SUTURE PLACEMENT SURGERY, AN ENDOTHELIAL CELL COUNT WAS OBTAINED. MY ENDOTHELIAL CELL COUNT WAS ASSESSED TO BE 613. PRIOR TO THE SURGERIES (TORIC LENS ROTATION AND STITCH PLACEMENT), THE ENDOTHELIAL CELL COUNT OF MY RIGHT EYE WAS 840. IN OTHER WORDS, A 27% REDUCTION IN ENDOTHELIAL CELL COUNT. I SUSPECT THAT VERY LITTLE OF THE ENDOTHELIAL DAMAGE WAS CAUSED BY THE TORIC LENS ROTATION SURGERY BECAUSE THAT SURGERY WAS QUICK, UNEVENTFUL, AND FELT LIKE NOTHING HAD HAPPENED AFTER THE SURGERY. WHEREAS THE STITCH PLACEMENT SURGERY WAS THE MOST TRAUMATIC THING THAT'S EVER HAPPENED TO MY EYE - SEVERE SWELLING TO THE POINT THAT I COULD BARELY OPEN MY EYE, PROFUSE TEARING AND IRRITATION, SUBSTANTIAL PAIN, AND AN IOP SPIKE TO AT LEAST 41 MM HG. I SUSPECT I SUFFERED A MILD TO MODERATE CASE OF TASS, BROUGHT ON BY A SUBCONJUNCTIVAL INJECTION OF VANCOMYCIN. REFERENCE REPORT #MW5164796.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1058652 TORIC LENS LENS, INTRAOCULAR, TORIC OPTICS MJP UNK

Patients

Seq Age Sex Outcome Treatment
1 67 YR Male Required Intervention LOSARTAN| VANCOMYCIN