• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ NATURAL SINGLEPIECE IOL; INTRAOCULAR LENS

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ NATURAL SINGLEPIECE IOL; INTRAOCULAR LENS Back to Search Results
Model Number SN60WF
Device Problems Material Opacification (1426); Scratched Material (3020)
Patient Problems Dry Eye(s) (1814); Corneal Clouding/Hazing (1878); Visual Disturbances (2140); Ptosis (2620); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 09/23/2015
Event Type  Injury  
Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
 
Event Description
A reported was received from (food and drug administration) fda and stated that following intraocular lens (iol) implanted procedure patient needed reading glasses to read.But over the following weeks to months, patient started having other problems besides not being able to read without glasses and having no depth perception, first was that patient vision had again become cloudy or hazy with just a few weeks.The physician determined it was posterior capsular opacification, a supposedly common occurrence.A yag laser treatment was used to clear the back of the capsule the lens sits in.Patient vison returned to normal with 20/20 vision in that eye, but it did not end the problems.At just after the 3 months point, patient started seeing double and over time patient eyelids started to droop (ptosis) to the point where i had to lift them with fingers to read.Patient was finally sent to see an ophthalmologist who specializes in ted (thyroid eye disease) and diplopia.Physician stated that both patient eyes tracked equally, but felt patient had issues with ptosis.Physician sent patient to a plastic surgeon who then scheduled a performed a blepharoplasty in 2022, but patient eyelids continued to droop again over time.It was suggested that patient had dry eyes and needed moisturizing drops, prisms in patient eyeglasses, and a host of other things that did not work or correct the problem.Patient started seeing a new ophthalmologist and physician finally took patient double vision seriously after complaining that patient now am seeing triple at times, the more the day goes on, the worse patient vision becomes, yet patient vision test comes back as having almost 20/20 vision.Physician sent patient back to the first ted/diplopia doctor whom patient visited, and physician determined that patient did not have ted (thyroid eye disease) but physician felt the problem was either the implanted lens, the capsule it was implanted in or patient cornea.Physician also felt patient vision issue was monocular diplopia in patient left eye, so patient don't know how he assumed it's monocular diplopia as no other test were done to rule this out.Physician then stated at this time there is no remedy for the issues patient having, and surgery at this point is impossible as would only damage or destroy the capsule, so there is no replacing it.Many ophthalmologists at this point have reported removing and replacing lenses damage during the safe three-month period because of the material the lens is made of, stating it is too soft and damaged easily during implantation, or by the devices or the surgeon used.Patient have been followed for many years until recently when patient was diagnosed with wet amd (age-related degeneration) of 2019 before the pandemic, being that patient had a ted (thyroid eye disease).At this time patient visits are now every two months for injections to treat the disease.It has never been reported by any ophthalmologist until now that they've see damage to the lens while looking at patient eyes.Patient stated that lens is defective with cloudiness and possible scratches.Lens cannot be explanted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ACRYSOF IQ NATURAL SINGLEPIECE IOL
Type of Device
INTRAOCULAR LENS
Manufacturer (Section D)
ALCON RESEARCH, LLC - HUNTINGTON
6065 kyle lane
huntington WV 25702
Manufacturer (Section G)
ALCON RESEARCH, LLC - HUNTINGTON
6065 kyle lane
huntington WV 25702
Manufacturer Contact
jonathan schlech
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8007579780
MDR Report Key17895784
MDR Text Key325251709
Report Number1119421-2023-01724
Device Sequence Number1
Product Code HQL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P930014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 10/09/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/09/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSN60WF
Device Catalogue NumberSN60WF.XXX
Device Lot NumberASKU
Was Device Available for Evaluation? No
Date Manufacturer Received09/14/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-