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

Model Number VICMO13.2

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems Headache (1880); Intraocular Pressure Increased (1937); No Code Available (3191)

Event Date 01/30/2017

Event Type  Injury  

Manufacturer Narrative

This product is not marketed in the us.(b)(4).

Event Description

The reporter indicated that the surgeon implanted a 13.2mm vicmo13.2 implantable collamer lens, -9.0 diopter, in the patient's right eye (od) on (b)(6) 2017.The patient experienced headache, elevated iop.The customer states there was no center hole on the lens.On (b)(6) 2017 the lens was exchanged and the problem was resolved.As of the day of mdr submission, the lens has not been returned.

Manufacturer Narrative

Device evaluation: the lens was returned in small vial, there was moisture on the lens.Visual inspection found no visible damage, no hole on the lens, clear surgical residue on lens surface, and there was ink staining on the surface of the lens.The lens was remeasured, and passed the lens verification.(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
• MDR Report Key: 6453292
• MDR Text Key: 71498674
• Report Number: 2023826-2017-00534
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 03/05/2017

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: 08/31/2018
• Device Model Number: VICMO13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/05/2017
• Initial Date FDA Received: 04/03/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2015
• 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 Outcome(s): Required Intervention
• Patient Age: 18 YR