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

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.

• 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 Key: 8297681
• MDR Text Key: 134772654
• Report Number: 1119421-2019-00125
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• 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 Number: SN60WF
• Device Catalogue Number: SN60WF.XXX
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2019
• Initial Date FDA Received: 02/01/2019
• 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 Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR