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

Model Number SN6AT7

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

Patient Problems Corneal Edema (1791); Endophthalmitis (1835); Erythema (1840); Hemorrhage/Bleeding (1888); Hypopyon (1913); Inflammation (1932); Pain (1994); Visual Impairment (2138)

Event Date 12/13/2018

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 similar complaints reported in the lot number.(b)(4).

Event Description

A surgeon reported several cases of toxic anterior segment syndrome/inflammation/endophthalmitis following intraocular lens (iol) implant procedures dating back to late 2017.The reporter did not specify which adverse event mentioned was related to this specific case.Additional information was provided indicating that no cultures were performed for this specific case.Additional information was provided by the physician, who reported that on the 5th postoperative day the patient presented with anterior segment inflammation, 2+ conjunctival inflammation, 3+ aqueous cell, aqueous fibrin, hypopyon, pain, milky vision, tenderness, redness and mild corneal edema.The patient was diagnosed with endophthalmitis and a negative culture result.The patient was referred to a retina consultant for tap and injection.Intravitreal injection antibiotics and tap performed.The intervention was effective and the outcome of the event resolved.The patient subsequently had a pre-retinal hemorrhage and a small vitreous hemorrhage which resolved.

• 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: cindy milam ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152231
• MDR Report Key: 8507024
• MDR Text Key: 141724606
• Report Number: 1119421-2019-00466
• Device Sequence Number: 1
• Product Code: MJP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/11/2019

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: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: SN6AT7
• Device Catalogue Number: SN6AT7U120
• Device Lot Number: 12543082
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2019
• Initial Date FDA Received: 04/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR