CRYSTALENS IOL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-12 for CRYSTALENS IOL manufactured by Bausch & Lomb, Inc..

Event Text Entries

[179505350] My problem results from a domino effect. I originally had bi-lateral cataract surgeries in (b)(6) 2017 using the crystalens iol. I had worsening symptoms of seeing halo's with lights, ghosting of images, and dry eye, and decrease in vision. Then i had bilateral yag procedures which did not help my case. Then my dr did a bilateral lasik procedure and everything worsened. My dry eyes became unbearable - necessitating steroids and prescription drops. A macular pucker then developed in my left eye due to the inflammation caused by the surgeries. Then i was put on long term steroid use, and now i have glaucoma in both eyes. I have a decrease field of vision in my right eye; and there are times i am unable to see clearly at all out of my left eye. I've had to have mris to rule out optic nerve or brain tumor it is so bad. I'm a poor candidate for eye surgery (obviously) but i may require a vitrectomy in my left eye. I believe all of this is caused by not only the original cataract surgery but definitively worsened with the lasik surgery. I still do not have distance vision and i have awful close up vision. I require glasses to see both near and far. Special drops at night in order to drive, restasis for my dry eyes, latanoprost for my glaucoma, preservative free drops 4 or more times a day, preservative free eye gel at night, hot compresses 2x/day. Omega 3's and taurine supplements, and regular quarterly visits to the corneal specialist and retinal specialist. Anyone who thinks that eye surgeries are without risks is fooling themselves, although i was told this risk was minimal and maybe only 1 pt a year had complications in that practice. The public needs to know that complications are real and devastating. This has totally changed my life. Hypercholesterolemia - controlled, finding of increased blood pressure (finding) - controlled epiretinal membrane of left eye. Posterior vitreous of left eye, glaucoma of left eye, glaucoma of the right eye, glaucomatous atrophy (cupping) of optic disc primary open angle glaucoma posterior vitreous detachment of right eye. Macular puckering, hypertensive retinopathy, vitreous degeneration, visual loss, keratoconjunctivitis sicca, not specified as sjogren's other inflammation for eyelids, presbyopia. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5092989
MDR Report Key9706718
Date Received2020-02-12
Date of Report2020-02-08
Date of Event2017-12-15
Date Added to Maude2020-02-13
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameCRYSTALENS IOL
Generic NameFOLDERS & INJECTORS, INTRAOCULAR LENS
Product CodeMSS
Date Received2020-02-12
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerBAUSCH & LOMB, INC.

Device Sequence Number: 2

Brand NameLASIK
Generic NameEXCIMER LASER SYSTEM
Product CodeLZS
Date Received2020-02-12
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No2
Device Event Key0
ManufacturerUNK
Manufacturer AddressUNK UNK


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-02-12

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