MAUDE Adverse Event Report: ALCON LABS ALCON ACRY SOFT LENS

Model Number SN60WF

Device Problems Break (1069); Component Falling (1105); Crack (1135); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem Eye Injury (1845)

Event Date 01/29/2014

Event Type  No Answer Provided  

Event Description

During the insertion of the intraocular lens implant of an alcon foldable iol, model #sn60wf, it was found that the implant had cracked and a piece had broken off.Thus, viscoat was placed more in the anterior chamber to coat the implant, and the implant was cut in several pieces for removal.However, one piece fell back and ripped the capsule and fell back into the superior aspect of the vitreous chamber.Diagnoses: dense cataract.

• Brand Name: ALCON ACRY SOFT LENS
• Type of Device: SOFT LENS
• Manufacturer (Section D): ALCON LABS; fort worth TX 76134
• MDR Report Key: 3622313
• MDR Text Key: 4177129
• Report Number: MW5034244
• Device Sequence Number: 1
• Product Code: LPN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/05/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Model Number: SN60WF
• Device Lot Number: 121971011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2014
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 128