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

Model Number VTICMO 13.2

Device Problem Optical Decentration (1360)

Patient Problem No Code Available (3191)

Event Date 08/24/2015

Event Type  Injury  

Manufacturer Narrative

This product is manufactured in the u.S.But not marketed in the u.S.Diopter: -13.0/3.0/x086.Device evaluated by manufacturer? no, lens remains implanted.(b)(4).Method: evaluation method: lens work order search.Results: evaluation results: a lens work order search was performed and no similar complaint was found.Conclusions: no conclusion can be drawn: based on the complaint history and work order search, a specific root cause of the event could not be determined.(b)(4).

Event Description

The reporter indicated the surgeon implanted a 13.2mm vticmo13.2, -13.00/+3.0/x086 diopter implantable collamer lens in the patient's right eye (od) on (b)(6) 2015.On (b)(6) 2015 a refractive surprise was noted.The lens remains implanted.A supplemental medwatch will be submitted then additional information is available.

• Brand Name: ICL (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: 5092392
• MDR Text Key: 26349381
• Report Number: 2023826-2015-01170
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Report Date: 08/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/31/2018
• Device Model Number: VTICMO 13.2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2015
• 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
• Patient Age: 33 YR