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

Model Number NANOPOINT

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/25/2016

Event Type  malfunction  

Manufacturer Narrative

Pt weight: unk.Expiration date - unk.Implant and explant dates: n/a.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.Mfg date: unk.(b)(4).Device not returned.

Event Description

The reporter stated an cc4204a collamer single piece lens +20.5 diopter tore during the loading process.The reporter indicated the nanopoint inserter tore the lens and there was no patient contact.The reporter stated there was no additional information to provide.

• Brand Name: VISIAN NANOPOINT 2.0 INJECTOR
• Type of Device: INTRAOCULAR LENS FOLDERS 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: 5934438
• MDR Text Key: 54151220
• Report Number: 2023826-2016-01152
• 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: 08/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2016
• 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: 08/10/2016
• 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
• Treatment: CARTRIDGE MODEL - NANOPOINT - LOT NUMBER UNK; LENS MODEL: CC4204A SERIAL #(B)(4)
• Patient Age: 65 YR