MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF MULTIPIECE EXPAND SERIES IOL; INTRAOCULAR LENS

Model Number MA60MA

Device Problem Positioning Problem (3009)

Patient Problems Cyclitis (1799); Hemorrhage/Bleeding (1888); High Blood Pressure/ Hypertension (1908); Inflammation (1932); Intraocular Pressure Increased (1937); Red Eye(s) (2038); Blurred Vision (2137); Eye Pain (4467); UGH (Uveitis Glaucoma Hyphema) Syndrome (4470); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/01/2017

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.The complaint history and product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.The product investigation could not identify a root cause.Root cause: the reporter stated that if the iol is not placed properly, excessive movement of the lens may result in chafing, pigment dispersion and breakdown of the blood-aqueous barrier, leading to recurrent hyphema, raised iop and anterior uveitis.Complete coverage of the optic periphery by the capsulorhexis edge and symmetrical centralization of iol in-the-bag could decrease the prevalence of interaction with the posterior iris surface.Although the edge design is discussed as a factor, there is no evidence that the issue would have occurred if the lens were properly positioned in the eye.The manufacturer internal reference number is: (b)(4).

Event Description

In a literature article titled uveitis glaucoma-hyphema syndrome associated with an in-the-bag square-edge intraocular lens, the authors present details of a single case.A 54 year presented with recurrent redness and blurred vision of the left eye with elevated intraocular pressure (iop) for one year.This patient had uneventful cataract phacoemulsification and posterior chamber intraocular lens (iol) implantation for both eyes at the local hospital.Her personal history included 6 diopters of myopia.The patient was discharged with a best-corrected visual acuity (bcva) of 20/20.Eleven months after surgery, the patient presented with sudden acute blurred vision, redness and pain in her left eye and was diagnosed with "iridocyclitis" at a local hospital.The patient was treated with topical antibiotics, steroids and non-steroidal anti-inflammatory medications.The inflammation was steroid responsive; however, it was not completely controlled after long-term treatments.Moreover, after 4 months of topical administration, the iop was higher than 50 mmhg.The patient developed intermittent ocular inflammation and hypertension, and then she received topical corticosteroids and anti-glaucoma treatment.Over 16 months, she reported six similar episodes, but the remission interval became progressively shorter.The patient finally sought help approximately 2 years following the implantation at our hospital.The patient was administered a diuretic.Pigmented keratic precipitates (kp), tyndall positive, red blood cell floating and iris depigmentation was also found in the left eye.After the pupil was dilated, it was found that the iol was not completely covered by the capsule edge, and a small amount of pearls can be seen on the posterior capsule.There was a significant accumulation of brown pigment at the upper edge of the iol.The three-piece iol with square edges was located in the capsule with slight forward displacement.The upper part of the iol was close to the iris.The patient reported that blurred vision would get worse after running or exercise.The patient was diagnosed with uveitis-glaucoma-hyphemia (ugh) syndrome.The anterior square edge of the iol resulted in iris chafing which further led to elevated iop, bleeding and inflammation.To solve the iris friction, the iol was removed from the capsule to control the iop and inflammation.It was replaced with different lens model.The replacement model design and overall length ensured full coverage of the implanted iol by the capsulorhexis edge.The iop and inflammation were immediately controlled after surgery.One year after the iol replacement, the patient remained asymptomatic, the bcva 20/30, the iop was less than 20mmhg without topical hypotensions and the visual acuity was stable.No additional bleeding or pigment dispersion episodes occurred after surgery.No further information is expected.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF MULTIPIECE EXPAND SERIES IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 11125444
• MDR Text Key: 226229711
• Report Number: 1119421-2021-00039
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MA60MA
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR