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

Model Number SN6AT7

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Endophthalmitis (1835); Hypopyon (1913)

Event Date 07/30/2015

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.(b)(4).

Event Description

A doctor reported endophthalmitis following an intraocular lens (iol) implant procedure.The patient experienced "hard vision" and was diagnosed with a hypopyon.The lens was explanted and a vitrectomy and anterior chamber washout were performed.The symptoms have resolved and another implant surgical procedure is scheduled.The lens was discarded.Culture was obtained and the result was negative.

Manufacturer Narrative

Product evaluation: product history records were reviewed and documentation indicated the product met release criteria.The cartridge product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.

Event Description

Additional information was provided that the patient also experienced eye pain, hyperemia and corneal edema.Symptoms recovered after 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: eddie darton, md, jd ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 5127150
• MDR Text Key: 27446236
• Report Number: 1119421-2015-06358
• 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
• Report Date: 10/05/2015

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: 09/30/2019
• Device Model Number: SN6AT7
• Device Catalogue Number: SN6AT7Q225
• Device Lot Number: 12322801
• Other Device ID Number: 00380652315876
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2014
• 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: ASICO INJECTOR; BENOXIL; BSS PLUS; MONARCH D CARTRIDGE; OPELEAD; VANCOMYCIN; ASICO INJECTOR
• Patient Outcome(s): Required Intervention; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female