MAUDE Adverse Event Report: ALCON LABS INTRAOCULAR LENS

Model Number LENS IO SN60WF 19.0-S12461045048

Device Problem Air Leak (1008)

Patient Problems Loss of Vision (2139); Toxicity (2333)

Event Date 02/21/2017

Event Type  Injury  

Event Description

Development of toxic anterior segment syndrome (tass) after cataract extraction and insertion of posterior chamber intraocular lens.Placement of lens on (b)(6) 2017 and onset of progressive loss of vision on (b)(6) 2017.Multiple visits over the subsequent weeks for medications and intra-cameral air bubbles.Event reported to (b)(6) and reviewed by our internal pt safety committee with a root cause analysis.Investigation revealed all disposable surgical instruments were used during the (b)(6) 2017 surgery, no instruments were sterilized "in house." the implant was manufactured by alcon labs; serial number (b)(4); implant name lens io sn60wf 19.0-(b)(4).

• Brand Name: INTRAOCULAR LENS
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON LABS
• MDR Report Key: 6906742
• MDR Text Key: 88005539
• Report Number: MW5072543
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LENS IO SN60WF 19.0-S12461045048
• Device Catalogue Number: LENS IO SN60WF 19.0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 70 YR