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

Model Number VTICMO13.2

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Blurred Vision (2137); Overwear Syndrome (2234)

Event Date 01/02/2017

Event Type  Injury  

Manufacturer Narrative

The product is manufactured in the u.S.But is not marketed in the u.S.Work order searches: no similar complaints were reported for units within the same lot.Claim #(b)(4).Lens not returned.

Event Description

The reporter indicated that the surgeon implanted a 13.2mm vticmo13.2, -15/0.5/149 diopter, implantable collamer lens in the patient's left eye (os) on (b)(6) 2016.The reporter stated excessive vault, glare/haloes, and photophobia was observed on (b)(6) 2017.The lens remains implanted as of (b)(6) 2017.

Manufacturer Narrative

Corrected data: excessive vault, glares/haloes, and photophobia was observed on (b)(6) 2017.(b)(4).

• Brand Name: ICL (IMPLANTABLE COLLAMER LENS)
• Type of Device: PHAKIC 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: michelle andres ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 6361178
• MDR Text Key: 68411761
• Report Number: 2023826-2017-00262
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 07/31/2019
• Device Model Number: VTICMO13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2017
• Initial Date FDA Received: 02/27/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2016
• 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 Outcome(s): Required Intervention
• Patient Age: 40 YR