MAUDE Adverse Event Report: STAAR SURGICAL COMPANY VISIAN NANOPOINT 2.0 INJECTOR; INTRAOCULAR LENS FOLDER AND INJECTORS

Model Number NANOPOINT

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by manufacturer? no.The product pertaining to this complaint was not returned for evaluation.However, the lens was returned and visual inspection of the returned product found the lens was torn.The lens was returned in liquid.Claim # (b)(4).Device not returned.

Event Description

The reporter stated the surgeon inserted the cc4204a collamer single piece lens +19.5 diopter and the lens was noted to be damaged.The surgeon removed the lens and no patient injury was reported.The reporter indicated the inserter tore the lens when loading.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch report will be submitted.

• Brand Name: VISIAN NANOPOINT 2.0 INJECTOR
• Type of Device: INTRAOCULAR LENS FOLDER AND INJECTORS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: michelle andres ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 5809979
• MDR Text Key: 50067500
• Report Number: 2023826-2016-00962
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: NANOPOINT
• Device Catalogue Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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