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 Conjunctivitis (1784); Unspecified Infection (1930)

Event Date 11/12/2018

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 facility representative reported that following an intraocular lens (iol) implant procedure, the patient experienced a possible infection.Additional information was provided by a facility representative, who reported that in the surgeon¿s opinion it is unknown what caused or contributed to the event.The patient was diagnosed with endophthalmitis and required an intravitreal injection of antibiotics.The patient¿s issues have not resolved.The nurse also reported conjunctival inflammation of 1+ diffuse injection and 2+ aqueous cell.The diagnosis is infectious endophthalmitis.The culture was negative.No organisms noted on culture.No growth after 48 hrs.The event outcome is improving.

• 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 ; 8176152230
• MDR Report Key: 8223612
• MDR Text Key: 132280129
• Report Number: 9612169-2019-00005
• 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: Nurse
• Type of Report: Initial
• Report Date: 01/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2023
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.160
• Device Lot Number: 21213740
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2018
• 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: BALANCED SALT SOLUTION; FORTAZ INJECTION; INFINITI UNIT AND HANDPIECE; MONARCH CARTRIDGE; MONARCH II HANDPIECE; MOXIFLOXACIN; POVIDONE IODINE 0.5%; VISCOAT
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR