MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. ACRYSOF IQ NATURAL SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number SN60WF

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Unspecified Infection (1930); Inflammation (1932)

Event Date 05/19/2018

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 physician reported a case of toxic anterior segment syndrome/inflammation/endophthalmitis following an intraocular lens (iol) implant procedure.Additional information has been provided indicating that only one case was culture proven endophthalmitis.This specific case had a positive culture result.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Event Description

Additional information was provided indicating that there was 1+ conjunctival inflammation, 3+ aqueous cell, aqueous fibrin and hypopyon.The patient experienced blackness of vision, dark lines, spots, photophobia, sharp shooting pain and foggy vision.The signs and symptoms were reported approximately 10 days postoperative.In the surgeon¿s opinion, this is late onset endophthalmitis and low virulence staph.Cultures were performed and the results were positive for staph and negative for coag.Moderate growth of staph coag negative (a).Three days later, the patient was given iv antibiotics.Approximately 3 weeks later a vitrectomy was performed.The intervention for the event was effective.The outcome of the event resolved.

• Brand Name: ACRYSOF IQ NATURAL SINGLEPIECE IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• MDR Report Key: 8493386
• MDR Text Key: 141261149
• Report Number: 9612169-2019-00040
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/12/2019

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: 12/31/2022
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.270
• Device Lot Number: 21209732
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/13/2019
• Initial Date FDA Received: 04/08/2019
• Supplement Dates Manufacturer Received: 04/01/2019
• Supplement Dates FDA Received: 04/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BALANCE SALT SOLUTION; BESIVANCE; CUSTOM PACK; FLUID MANAGEMENT SYSTEM; LIDOCAINE; PHACO TIP; POVIDONE IODINE 10%; POVIDONE IODINE 5%; PROVISC; UNSPECIFIED HANDPIECE; VISCOAT
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 70 YR