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

Model Number SV25T3

Device Problem Insufficient Information (3190)

Patient Problems Corneal Edema (1791); Unspecified Infection (1930); Inflammation (1932)

Event Date 01/16/2018

Event Type  Injury  

Manufacturer Narrative

Product evaluation: the product was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.Additional information has been requested.The manufacturer internal reference number is: (b)(4).

Event Description

A customer reported following a micro-stent implant and intraocular lens implant (iol) procedure, a patient developed an infection.The infection was confirmed by a positive culture.On post op day one the patient's eye was severely inflamed with moderate corneal edema and hypopyon.On post op day two the anterior chamber was tapped.The cultures demonstrated 'normal skin flora'.The patient was treated with topical antibiotics, steroids, and glaucoma medications.Continued improvement was noted.

• Brand Name: ACRYSOF IQ RESTOR TORIC SINGLEPIECE IOL
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 7395713
• MDR Text Key: 104295340
• Report Number: 1119421-2018-00365
• Device Sequence Number: 1
• Product Code: MJP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: SV25T3
• Device Catalogue Number: SV25T3U215
• Device Lot Number: 12539300
• Other Device ID Number: 00380652311243
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2017
• 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: INTRAOCULAR CEFTAZIDIME; INTRAOCULAR VANCOMYCIN; UNKNOWN GLAUCOMA MEDICATION; UNKNOWN STEROID; UNKNOWN TOPICAL ANTIBIOTIC
• Patient Outcome(s): Required Intervention