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

Model Number SN6AT5

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

Patient Problems Endophthalmitis (1835); Hyperemia (1904); Blurred Vision (2137)

Event Date 11/29/2018

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 physician reported that a patient developed endophthalmitis approximately 15 months following an intraocular lens (iol) implant procedure.The patient experienced blurred vision and hyperemia.A vitrectomy was performed.The visual acuity recovered.The iol remains implanted.Additional information has been requested.

Manufacturer Narrative

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

Event Description

Additional information was provided indicating that the approximately 15 months following an intraocular lens (iol) implant procedure, the patient had developed hyperemia, keratic precipitates, anterior chamber cells and hypopyon.An anterior chamber washout and a vitrectomy were performed.A bacteriological test was performed with a negative result.The patient was treated with steroid, antibiotic and non-steroidal anti-inflammatory medication.The symptoms have improved.

• Brand Name: ACRYSOF IQ TORIC SINGLEPIECE IOL
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 8240121
• MDR Text Key: 132808214
• Report Number: 1119421-2019-00059
• Device Sequence Number: 1
• Product Code: MJP
• Combination Product (y/n): N
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 06/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: SN6AT5
• Device Catalogue Number: SN6AT5Q250
• Device Lot Number: 12509282
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PANIMYCIN 0.3CC INJECTION; STEROID INJECTION; TRYPAN BLUE
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR