MAUDE Adverse Event Report: CARL ZEISS MEDITEC, INC. VISUMAX FEMTOSECOND LASER; FEMTOSECOND LASER SYSTEM

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Dry Eye(s) (1814); Flashers (1864); Vitreous Floaters (1866); Pain (1994); Red Eye(s) (2038); Vertigo (2134); Visual Disturbances (2140); Anxiety (2328); Depression (2361); Vitreous Detachment (2445); No Code Available (3191)

Event Date 02/06/2016

Event Type  Injury  

Event Description

I had the lasik eye surgery and i have been suicidal and depressed since the surgery.Before lasik i had no eye problems whatsoever.I used the same glasses for 10 years.I went to one of the best ophthalmologists in my area and he used the most up to date technology and paid a very high price.I was never warned about any of the debilitating side effects that i experienced after lasik.I am young and i have had nothing but eye problems since i had lasik.They told me that i would only experience halos and dry eye for no more than a few weeks and i would have "hd" vision.I cannot believe how unregulated this procedure is and how your organization have failed in informing and protecting the public.They told me that i was a perfect candidate.After the procedure, i could not operate for 6 months.My eyes were filled with huge floaters that caused distortion and glare.I have double vision that i never experienced with my glasses.I have severe pain behind my eyes and i cannot sleep at night because of the dry eyes.My eyes are red all the time.I spent almost (b)(6) on second opinions and other doctors.Most of the doctors protected each other's interest and lied to me about the injuries that had been caused by the lasers that your organization have approved.I finally found a honest retina specialist that had no interest who had done my lasik.He concluded that i suffered from a vitreous detachment.This is alarming because i am not myopic.I was never warned about floaters or virtuous detachment, but i found numerous forms and studies that link this injury with lasik.I am also suffering from debilitating dry eye one year after lasik.Lasik has pretty much ruined my life.I used to work on the computer for hours without any issues and i can't even look at the screen for more than 10 minutes.I cannot enjoy the normal things that i used to enjoy like watching tv.I have been suffering e very day since this surgery.I was misinformed and sold on a procedure that is potentially dangerous and harmful.I was never informed about risks like epithelial ingrowth (which i have), dry eye pain, vertigo, poor eye muscle function, vitreous detachment, red eyes, distorted peripheral vision.I also experienced flashes in my eye.I can't drive at night and have no social life anymore.When i mention all the problems to my doctor he simply ignores me and i know that none of my injuries caused by lasik is being reported.These doctors have a lot of financial interest and downplay how severe lasik complications can be.It seems that your organization has done nothing to stop this.I didn't make an informed decision.They gave me a consent form the day of my surgery and i did not have time to review them.This is both unethical and immoral.If someone wants to take risks with their eye sight, they must make an informed decision.These businessmen with md's are making decisions for people without informing them.This is fraud and your organization has done nothing to stop it.Shame on you.Effect of microkeratome suction during lasik on ocular structures.April 2005 volume 112, issue 4, pages 645-649 incidence of positional vitreous detachment after laser in situ keratomileusis graefes arch clin exp ophthalmol.On 07/26/2005; 1-5 vitreoretinal alterations following laser in situ keratomileusis: clinical and experimental studies.Graefes arch clin exp ophthalmol.On july 2001; (6): 416-23 how refractive surgery causes posterior vitreous detachment (pvd) presented at: american academy of ophthalmology annual meeting, november 2003; anaheim, california [comparison of posterior vitreous detachment after femtosecond laser and microkeratome - assisted laser in situ keratomileusis].Zhonghua yan ke za zhi.April 2013; 49(4):309-14.

• Brand Name: VISUMAX FEMTOSECOND LASER
• Type of Device: FEMTOSECOND LASER SYSTEM
• Manufacturer (Section D): CARL ZEISS MEDITEC, INC.
• MDR Report Key: 6475210
• MDR Text Key: 72264818
• Report Number: MW5068977
• Device Sequence Number: 0
• Product Code: OTL
• 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: 04/06/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: OTC MEDS: VITAMIN C.; RX MEDS: NONE.
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 33 YR
• Patient Weight: 79