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

Model Number SN6AT6

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

Patient Problems Headache (1880); Pain (1994); Blurred Vision (2137)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

The product was not returned.Complaint history and product history records could not be reviewed because the literature report did not provide a lot number or any identification traceable to the manufacturing documentation.A malfunction has not been indicated against the lens.The file has been opened from a literature report: pseudouveitis and iris atrophy in pigment dispersion syndrome after sulcus implantation of a one-piece iol with square edge haptics.The clinical findings were pigment dispersion syndrome, secondary to the iol in the sulcus rubbing against the iris.The symptoms resolved after 1.5 years.The lens remaining implanted.The directions for use state the lens is intended for placement in the capsular bag.The safety and effectiveness of a posterior chamber lens, if placed in the anterior chamber, has not been established.The placement of the iol in the sulcus may be a potential contributory factor.The manufacturer internal reference number is: (b)(4).

Event Description

In a literature report entitled "pseudouveitis and iris atrophy in pigment dispersion syndrome after sulcus implantation of a one-piece iol with square edge haptics", the author discussed a patient with pigment dispersion syndrome following intraocular lens (iol) implantation in the ciliary sulcus.The patient was mistakenly treated for non-granulomatous anterior uveitis.She developed irvine-gass syndrome in the right eye post-operatively with episodes of ocular pain, blurred vision, and headaches, starting a few months after the procedure.She was treated with a topical steroid and hypotensive drugs.Iris atrophy, capsular folds and a capsular tear were present on postoperative examination.It was noted that after several crises, the disease became self-limiting.

• Brand Name: ACRYSOF IQ TORIC SINGLEPIECE IOL
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 11140184
• MDR Text Key: 225782748
• Report Number: 1119421-2021-00052
• Device Sequence Number: 1
• Product Code: MJP
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: Physician
• Type of Report: Initial
• Report Date: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SN6AT6
• Device Catalogue Number: SN6AT6.210
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2020
• 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: 67 YR