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

Model Number MA60MA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); High Blood Pressure/ Hypertension (1908); Inflammation (1932); Intraocular Pressure Increased (1937); Irritation (1941); Pain (1994); Red Eye(s) (2038); Blurred Vision (2137); Visual Impairment (2138)

Event Date 08/01/2017

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: 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

In a literature article titled ¿uveitis-glaucome-hyphema syndrome associated with an in-the-bag square edge intraocular lens, the authors report the history and treatment of a patient diagnosed with ugh syndrome.A patient presented with recurrent redness, and blurred vision with elevated intraocular pressure (iop) for one year.A patient had an uneventful cataract phacoemulsification with posterior chamber intraocular lens (iol) implantation with a good visual result.Eleven months after surgery, the patient presented with sudden acute blurred vision, redness and pain, and was diagnosed with iridocyclitis.The patient was treated with topical antibiotic/steroid combination, topical steroid, and a topical non-steroidal anti-inflammatory drop.The inflammation is steroid responsive initially, 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 topical antibiotic/steroid combination was replaced by a topical steroid, a topical carbonic anhydrase inhibitor, and a topical beta blocker.The patient developed intermittent ocular inflammation and hypertension, then received topical corticosteroids and anti-glaucoma treatment.Over 16 months, the patient reported six similar episodes, but the remission interval became progressively shorter.She was diagnosed as posner-schlossman syndrome (pss) at a different facility, but there was still no effective improvement.The patient finally sought another opinion with the authors.The visual acuity (va) was 20/200, and iop was 31.5 mmhg after oral administration of a carbonic anhydrase inhibitor.Pigmented keratic precipitates (kp), tyndall (+), red blood cell floating and iris depigmentation was also found in the eye.The iol comprised three pieces with square edges of optical parts, which were located in the capsule bag.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.Gonioscopy revealed an open angle with unilateral dense pigment accumulation without iris vessel abnormalities or adherence in the eye.Ultrasonic biological microscopy (ubm), showed that the iol was in contact with the iris.The three-piece iol with square edges was located in the capsule with slight forward displacement.The upper optical part of the iol was close to the iris.No significant vitreous hemorrhage was found in the fundus.Additionally, no sign of hyphema, pseudoexfoliation syndrome or pigment dispersion was found in the fellow eye with a well-centered in-the-bag iol.The case was diagnosed as uveitis-glaucoma-hyphema (ugh) syndrome.The anterior square edge of iol resulted in iris chafing which further led to persistent elevated iop, bleeding and inflammation.To solve the iris friction, the iol was removed from the capsule to control iop and inflammation, and was replaced by a hydrophilic acrylic acid posterior chamber iol.The iop and inflammation were immediately controlled after surgery.During follow-up of one year after iol replacement, the patient remained asymptomatic, the bcva was 20/30, the iop was less than 20 mmhg without topical hypotensors, and visual acuity was stable.No additional bleeding or pigment dispersion episodes occurred after surgery.We propose that the mechanism of ugh syndrome in this patient was the uncovered sharp square edges leading to iridociliary irritation and iris bleeding.The slight forward displacement of the iol caused chafing and active retro-iridian bleeding in the contact area between the iol and iris by the uncovered anterior square-edged iol.Scanning electron microscopy (sem) showed that the anterior square edge of the iol implanted in this patient was sharp and rough.

• 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
• 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: 9934188
• MDR Text Key: 186811778
• Report Number: 1119421-2020-00646
• 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,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2020
• 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