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

Model Number SN60WF

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

Patient Problem Keratitis (1944)

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.Complaint history and product history records could not be reviewed because the report did not provide a lot number or any identification traceable to the manufacturing documentation.The file has been opened from a literature report.There is no indication in the report that the iol caused/contributed to the reported events.The literature report: new surgical approach in cases of cataract with ocular stevens-johnson syndrome, describe the intraoperative difficulties encountered in cases of ocular stevens-johnson syndrome as a result of a poor ocular surface, the presence of symblepharon, and varying degrees of corneal opacity with secondary poor visibility of anterior segment structures.The formation of cataract in cases of ocular stevens-johnson syndrome occurs at an early age as a result of ongoing intraocular inflammation and prolonged use of topical steroids to control the inflammation.The key to successful cataract surgery in these patients is optimization of the ocular surface preoperatively, a modified technique of phacoemulsification, and close postoperative follow-up.Additional information has been requested.(b)(4).

Event Description

In a literature article, the authors describe the intraoperative difficulties encountered in cases of ocular stevens-johnson syndrome as a result of a poor ocular surface, the presence of symblepharon, and varying degrees of corneal opacity with secondary poor visibility of anterior segment structures.Modications to the standard phacoemulsification technique enabled safe and successful completion of the surgery in theses cases.Table one describes s.No.1 is a (b)(6), male, right eye, pre-existing dense with adherent leucoma cataract, stevens-johnson syndrome, implanted with an sn60wf iol, postoperative complication filamentary keratopathy, treated with copious lubrication.The eye developed filamentary keratitis at 1 month, which subsided with preservative free lubricants, cyclosporine and low dose surface acting steroids.Additional information has been requested.There are four medical device reports associated with this literature article.This report is for the first patient.

• 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: rita lopez ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514846
• MDR Report Key: 6274612
• MDR Text Key: 65665537
• Report Number: 1119421-2017-00125
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: Health Professional
• Type of Report: Initial
• Report Date: 01/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2017
• 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
• Date Manufacturer Received: 12/28/2016
• 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: 22 YR