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

Model Number SN60WF

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

Patient Problems Inflammation (1932); Pain (1994); Visual Impairment (2138); Toxicity (2333)

Event Date 10/21/2019

Event Type  Injury  

Manufacturer Narrative

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 physician reported that following an intraocular lens (iol) implant procedure, a patient developed toxic anterior segment syndrome (tass).On the 5th postoperative day, the patient had pain.The following day, the patient had 1-2+ cell, not too bad.The physician switched out one steroid eye medication for another and added an antibiotic fluoroquinolone medication.The patient did not show up for the follow up appointment.The daily attempts made to get her in were not successful.On the 12th postoperative day, the patient called the physician to report worsening pain and "dark" vision.The patient did not come in again.Additional information was provided indicating that the patient developed 1+ conjunctival inflammation, 1+ aqueous cell.The patient had postop pain, 1-2+ cell, decreased vision and photophobia.Slightly elevated inflammation on the 5th postoperative day without concern of endophthalmitis.It is unknown if the topical medication adjustment was effective as the patient has failed to show for daily checks for over 1 week.The outcome of the event is unknown.Other potentially contributing factors were reported as diabetes.

• Brand Name: ACRYSOF IQ NATURAL SINGLEPIECE IOL
• Type of Device: INTRAOCULAR LENS
• 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: 9347680
• MDR Text Key: 167194571
• Report Number: 1119421-2019-01942
• Device Sequence Number: 1
• Product Code: HQL
• 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: 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2019
• 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.190
• Device Lot Number: 12719156
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2019
• 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: BESIVANCE 4X; BSS 15ML-USA, 0065079515, 0007950004, FTW - NORTH; DUREZOL 6X; ILEVRO; LOTEMAX; UNSPECIFIED CUSTOM PAK, HTX; UNSPECIFIED HANDPIECE, UNKNOWN SYSTEM, ITC; UNSPECIFIED PROVISC OVD, 000451, BEL; UNSPECIFIED VISCOAT OVD, 000452, BEL
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR