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U.S. Department of Health and Human Services

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

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ALCON RESEARCH, LTD. - HUNTINGTON ACRYSOF IQ NATURAL SINGLEPIECE IOL; INTRAOCULAR LENS Back to Search Results
Model Number SN60WF
Device Problem Unexpected Therapeutic Results (1631)
Patient Problems Hemorrhage/Bleeding (1888); Blurred Vision (2137)
Event Type  Injury  
Manufacturer Narrative
Evaluation summary: the product was not returned.Complaint history and product history records could not be reviewed because the literature report did not contain a lot number or any identification traceable to the manufacturing documentation.A malfunction has not been indicated against the lens.The complaint was opened from a literature report: an imprint of intra ocular lens on an iris.In this case, report the authors presented a case of a lens that was implanted in the anterior chamber causing severe iris chafing with specific iol shape iris transillumination imprint and this probably caused ugh and vh.Per the report and the directions for use (dfu) for this specific lens model, the lens is designed specifically for implantation in the posterior chamber.Placing the lens in the anterior chamber is a failure to follow the dfu for the product.Report conclusion: the iol is designed specifically for implantation in the posterior chamber (bag).Placement in the anterior chamber should be avoided.(b)(4).
 
Event Description
In a literature article, the authors reported a case of a one piece intraocular lens (iol) that was implanted in the anterior chamber and caused uveitis glaucoma hyphema (ugh).The lens chafing the iris created an unusual appearance of iris transillumination defect in the shape of the intraocular lens.The case report is of a (b)(6) year old man that underwent cataract surgery four years ago, has arrived to the ophthalmology emergency room because of blurry vision.His visual acuity (va) was 20/50 and the intra ocular pressure (iop) was 30¿mmhg.In the anterior chamber (ac), red blood cells were found.Iris transillumination defects in the shape of one piece intra ocular lens were observed.The one piece iol was in the sulcus.Uveitis glaucoma hyphema (ugh) syndrome with vitreous hemorrhage (vh) was diagnosed so he got steroidal and anti glaucoma drops and referred to an exchange iol surgery.The iol exchange was performed.Ten day post operation, his va was 20/32, the iop was normalized and the aciol was in place.In this case report the authors presented a case of aciol that was implanted in the anterior chamber causing severe iris chafing with specific iol shape iris transillumination imprint and this probably caused ugh and vh.According to the authors, the one piece iol is designed specifically for implantation in the bag.Placement in the sulcus of a one piece iol should be avoided.
 
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Brand Name
ACRYSOF IQ NATURAL SINGLEPIECE IOL
Type of Device
INTRAOCULAR LENS
Manufacturer (Section D)
ALCON RESEARCH, LTD. - HUNTINGTON
6065 kyle lane
huntington WV 25702
Manufacturer (Section G)
ALCON RESEARCH, LTD. - HUNTINGTON
6065 kyle lane
huntington WV 25702
Manufacturer Contact
cindy milam
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152231
MDR Report Key8297681
MDR Text Key134772654
Report Number1119421-2019-00125
Device Sequence Number1
Product Code HQL
Combination Product (y/n)N
Reporter Country CodeIS
PMA/PMN Number
P930014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation Physician
Type of Report Initial
Report Date 02/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberSN60WF
Device Catalogue NumberSN60WF.XXX
Device Lot NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/09/2019
Initial Date FDA Received02/01/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age61 YR
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