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

Model Number SN60WF

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Failure of Implant (1924); Inflammation (1932); Intraocular Pressure Increased (1937); Pain (1994); UGH (Uveitis-Glaucoma-Hyphema) Syndrome (2115); Blurred Vision (2137)

Event Date 06/01/2011

Event Type  Injury  

Manufacturer Narrative

Product evaluation: 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.No malfunction has been indicated against the lens.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).

Event Description

In a literature article titled, diode laser transscleral cyclophotocoagulation (dltsc) for uveitis-glaucoma-hyphema syndrome, a physician reported that following a cataract extraction with intraocular lens (iol) implant procedure, a patient experienced distending pain of the eye and blurry vision over a period of a half a year.Intraocular pressure was significantly increased, with 3+ cell in the anterior chamber and vitreous opacity.Ultrasound biomicroscopy showed chafing between the iol and the posterior iris at 5 o'clock when the eye moved.The patient often bowed his head at work and caused the chafing between the iris and the iol.The patient had a rhegmatogenous retinal detachment with vitrectomy and perfluorocarbon gas in this eye one year prior to the cataract extraction.Because of this vitrectomy, the chafe was worse.His erythrocyte sedimentation rate and serum c-reactive protein concentration were normal.No abnormalities were found in systemic immunity and virus series tests.The patient was diagnosed with ugh syndrome.Medical management was tried first.However, neither iop nor inflammation could be controlled.The patient did not want the iol removed due to his worry of risks of surgical complications, so the dltsc approach was performed.The laser shrinks the ciliary processes, which may reduce the iris contact on the iol, thus relieving the chafing.The procedure was performed under local anesthesia (2ml of 2% lidocaine and 2ml 1.5% ropivacaine as a retrobulbar injection).The laser was set at an initial power of 1750mw and a duration of 2seconds.The laser power was to achieve a ¿burst¿ sound in roughly half of the laser applications.Laser applications were spaced evenly over the inferior 180 degrees, while sparing the 4- and 6-o¿clock regions, all 15 light condensation points.The patient was comfortable, there was no bleeding in the eye, and he was safe to return to the ward.After 12 months of follow up, bcva was 20/40 od and 20/25 os.Iop was 12mm hg od and 15mm hg os.There were no anterior chamber inflammation, no vitreous opacity, and, there was no contact between iol and the posterior surface of the iris.The fundus of the eye was clearly visible.

• 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 ; 8175514979
• MDR Report Key: 9929112
• MDR Text Key: 186570252
• Report Number: 1119421-2020-00624
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2020
• 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.195
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2020
• 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: 59 YR