FDA Adverse Event Injury Summary report: N

CRYSTALENS AO1UV

MDR report key: 15438317 · Received September 15, 2022

Report

Report Number
MW5112084
Event Type
Injury
Date Received
September 15, 2022
Date of Event
October 22, 2020
Report Date
September 13, 2022
Manufacturer
BAUSCH + LOMB INCORPORATED
Product Code
MJP
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
RI, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

MY OPHTHALMOLOGIST PERFORMED CATARACT SURGERY ON ME & INSERTED BAUSCH + LOMB TRULIGN TORIC INTRAOCULAR LENS IN MY LEFT EYE AND CRYSTALENS IN MY RIGHT EYE ON (B)(6) 2020. LITERATURE ONLINE AT THE TIME AND PROVIDED BY MY DR. SAID THESE WERE ACCOMMODATING IOLS AND THEY WOULD MIMIC THE NATURAL MOVEMENT OF MY EYE MUSCLES, CREATING LESS OF THE POSSIBILITY FOR DEPENDENCE ON SPECTACLES. IN ADDITION, THESE PREMIUM IOLS SUPPOSEDLY HAD MUCH LESS INCIDENCE OF GLARE AND HALOS FROM LIGHTS. VERY SOON AFTER CATARACT SURGERY, I HAD TO UNDERGO YAG LASER CAPSULOTOMY ON BOTH EYES (AT SEPARATE TIMES) FOR POSTERIOR CAPSULE OPACIFICATION. I STILL DID NOT SEE CLEARLY, AND MY EYES DID NOT FEEL WELL, LIKE THEY WERE CONSTANTLY FATIGUED & THEY WERE ALWAYS RED AND TIRED. DRIVING AT NIGHT WAS QUITE DANGEROUS AS THE GLARE FROM ANY LIGHT WAS EXTREME; MUCH MORE THAN ANYTHING I HAD EVER EXPERIENCED, AND MANY TIMES I COULD NOT SEE. MY COORDINATION CHANGED AND PERIPHERAL VISION WAS QUITE DIFFERENT. MY OPHTHALMOLOGIST WANTED TO FIT ME FOR SPECTACLES BUT COULD NOT EXPLAIN MY DIFFICULTIES. I THEN REALIZED FROM RECALLING THINGS HE SAID AND TOLD HIS ASSISTANTS, HE HAD FROM THE START SET ONE EYE TO BE A DISTANCE EYE AND ONE TO BE CLOSE UP, APPARENTLY BELIEVING THESE IOLS WERE NOT ACCOMMODATING. I WENT TO A RETINAL SPECIALIST IN (B)(6) TO BE EXAMINED TO SEE IF MY EYES WERE RUINED. I WAS TOLD MY IOLS WERE SCARRED IN PLACE AND I WAS FORTUNATE I COULD SEE, THAT MANY OTHERS WERE AFFECTED BY VAULTING. REGARDLESS, THEY DO NOT "ACCOMMODATE" AND BECAUSE THE LENSES ARE SO LARGE, THE RISK OF CAUSING BLINDNESS BY REMOVAL IS TOO GREAT UNLESS ABSOLUTELY NECESSARY. SHE ALSO SAID MY PUPILS ARE LARGER THAN AVERAGE, WHICH IS PROBABLY WHY I AM EXPERIENCING THE TREMENDOUS PROBLEMS WITH GLARE. EVERY DAY I AM SORRY I DECIDED TO TRY TO DO SOMETHING TO FIX MY VISION, WHICH ONLY MADE IT WORSE AND MY EYES MORE PAINFUL. NOT TO MENTION THE COST. SADLY, I DIDN'T REALIZE HOW EASY IT WAS FOR A COMPANY LIKE BAUSCH + LOMB TO GET APPROVAL FOR A DEVICE THAT CAN AFFECT EVERY DAY OF THE REST OF YOUR LIFE. FDA SAFETY REPORT ID# (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2356215 CRYSTALENS AO1UV LENS, INTRAOCULAR, ACCOMMODATIVE MJP BAUSCH + LOMB INCORPORATED
2522745 TRULIGN TORIC BL1UT LENS, INTRAOCULAR, TORIC OPTICS MJP BAUSCH + LOMB INCORPORATED

Patients

Seq Age Sex Outcome Treatment
1 62 YR Female Disability B2| BOTOX FOR MIGRAINE| CYMBALTA| D3| LISINOPRIL | MAGNESIUM| OMEPRAZOLE| RIZATRIPTAN| SIMVASTATIN | SYNTHROID| TROKENDI