MAUDE Adverse Event Report: STAAR SURGICAL COMPANY VISIAN TICL (IMPLANTABLE COLLAMER LENS); INTRAOCULAR LENS

Model Number VTICMO13.2

Device Problems Break (1069); Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/24/2014

Event Type  malfunction  

Event Description

The reporter indicated the surgeon attempted to use a 13.2mm vticmo13.2 implantable collamer lens.The lens was found to be defected/torn before loading process.There was no patient contact.

Manufacturer Narrative

This product is manufactured in the u.S but not marketed in the u.S.(b)(4).Evaluation method : work order search.Results: a lens work order search was performed and no similar complaints were found.Conclusions: based on the complaint history and work order search, a specific root cause of the event could not be determined.(b)(4).Device not returned to manufacturer.

Manufacturer Narrative

Event problem and evaluation codes: method code(s): (evaluation method): device history report review.Results code(s): (evaluation result) : device history report review: after review of the dhr, it has been determined that nothing in the manufacturing and packaging processes can be identified as the cause of this complaint.Based on the investigation, no definite root cause for the complaint is determined.Conclusion code(s): (evaluation conclusion): based on the complaint history, lens work order search and dhr review, a specific root cause of the event could not be determined.(b)(4).

• Brand Name: VISIAN TICL (IMPLANTABLE COLLAMER LENS)
• Type of Device: INTRAOCULAR LENS
• 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: althea watson ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 4338608
• MDR Text Key: 21242050
• Report Number: 2023826-2014-01144
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: LE
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor,distributor,forei
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2017
• Device Model Number: VTICMO13.2
• Other Device ID Number: DIOPTER -16.50/2.0/052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/11/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/15/2014
• 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: FOAM TIP PLUNGER MODEL AND LOT NUMBER - UNK; CARTRIDGE MODEL AND LOT NUMBER - UNK
• Patient Age: 29 YR