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

Model Number SN60WF

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

Patient Problems Corneal Edema (1791); Endophthalmitis (1835); Erythema (1840); Hypopyon (1913); Inflammation (1932); Pain (1994); No Code Available (3191)

Event Date 01/18/2018

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.(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 the patient experienced eye pain, redness, watering, 1-2+ corneal edema, pupillary fibrin, 3+conjunctival inflammation, 3+ aqueous cell, aqueous fibrin, and hypopyon.In the surgeon's opinion, there was no apparent cause.The patient was diagnosed with toxic anterior segment syndrome on the 4th postoperative day.No cultures performed.The patient was treated with steroids and antibiotics.The intervention was effective and 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
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: cindy milam ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152231
• MDR Report Key: 8507055
• MDR Text Key: 141723877
• Report Number: 9612169-2019-00042
• 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: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.190
• Device Lot Number: 21203458
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2019
• Date Device Manufactured: 10/19/2017
• 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: 70 YR