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

Model Number SN6AT9

Device Problem Insufficient Information (3190)

Patient Problems Edema (1820); Endophthalmitis (1835); Intraocular Pressure Increased (1937); Pain (1994); Blurred Vision (2137)

Event Date 11/01/2017

Event Type  Injury  

Manufacturer Narrative

Product evaluation: the product was not returned for analysis.Product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.Additional information has been requested.(b)(4).

Event Description

A doctor reported postoperative endophthalmitis following an intraocular lens (iol) implant procedure.The patient experienced eye pain, blurred vision, hyperemia, corneal edema and vitreous clouding following the procedure.The patient was treated with medication and intravitreal injections.They also experienced an increase in intraocular pressure (iop) for which the aqueous humor was drained in order to reduce the pressure.An emergency vitrectomy was performed at a nearby hospital and an anterior chamber wash-out was also performed.Symptoms improved following initial medical treatment.

• Brand Name: ACRYSOF IQ TORIC SINGLEPIECE IOL
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON RESEARCH, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7068470
• MDR Text Key: 93251251
• Report Number: 1119421-2017-01373
• Device Sequence Number: 1
• Product Code: MJP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: SN6AT9
• Device Catalogue Number: SN6AT9A190
• Device Lot Number: 12561893
• Other Device ID Number: 00380652372121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2017
• 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
• Treatment: BSS PLUS; IMIPENEM; PROVISC; SHELLGAN; XYLOCAINE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR