MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL W/ACRYSERT C DELIVERY SYSTEM; LENS, GUIDE, INTRAOCULAR

Model Number SN6CWS

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Swelling (2091); Blurred Vision (2137)

Event Date 07/26/2018

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.The product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A patient reported that after an intraocular lens (iol) implant surgery, he presented with blurry vision and swelling of the cornea.Drops were prescribed for the swelling for some time but the sight did not improve.The patient also was diagnosed at a later date with posterior capsular opacity.The patient has had a laser procedure to open the capsule.The patient states the vision has improved some but still is not satisfied.Additional information has been requested.

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL W/ACRYSERT C DELIVERY SYSTEM
• Type of Device: LENS, GUIDE, INTRAOCULAR
• 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: bryan blake ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7881242
• MDR Text Key: 120424445
• Report Number: 1119421-2018-01364
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 06/30/2021
• Device Model Number: SN6CWS
• Device Catalogue Number: SN6CWS.195
• Device Lot Number: 12477058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/03/2018
• Initial Date FDA Received: 09/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2016
• 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
• Treatment: MAXITROL EYE DROPS; VOLTAREN DISPERS; VOLTAREN EYE DROPS
• Patient Outcome(s): Required Intervention