MAUDE Adverse Event Report: BAUSCH & LOMB, INC. CRYSTALENS IOL ; FOLDERS & INJECTORS, INTRAOCULAR LENS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems High Blood Pressure/ Hypertension (1908); Inflammation (1932); Visual Impairment (2138); Visual Disturbances (2140); Halo (2227)

Event Date 12/15/2017

Event Type  Injury  

Event Description

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).

• Brand Name: CRYSTALENS IOL
• Type of Device: FOLDERS & INJECTORS, INTRAOCULAR LENS
• Manufacturer (Section D): BAUSCH & LOMB, INC.
• MDR Report Key: 9706718
• MDR Text Key: 179505350
• Report Number: MW5092989
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/08/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/12/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 73