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

Model Number VTICMO13.2

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Capsular Bag Tear (2639)

Event Type  Injury  

Event Description

The customer reported the surgeon implanted a 13.2mm vticmo13.2 implantable collamer lens in the patient's right eye (od) and the surgeon inadvertently hit the capsule when widening the incision.The lens was not implanted.On (b)(6) 2014.The surgeon was in training and event was due to a user's error.

Manufacturer Narrative

This product is manufactured in the u.S.But not marketed in the u.S.(b)(4).

Manufacturer Narrative

Event problem and evaluation codes: method code(s): (process evaluation): device history record review.Result code(s): (operational problem) : based on the results of the dhr review, the available information given within this complaint, and work order search, a conclusion can be drawn that nothing in the manufacturing, sterilization and packaging processes of the lens was likely to have contributed to the complaint.As reported by the surgery facility, the root cause of the complaint is user error as surgeon was under training.The product was not returned to staar for an evaluation.(b)(4).

Manufacturer Narrative

Patient's vision is 6/5^-1 despite mild noticeable lens changes.Report source is distributor, not user facility.Claim #(b)(4).

• 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: 4960647
• MDR Text Key: 19006854
• Report Number: 2023826-2015-01008
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,distributor,forei
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/10/2015

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: 01/31/2018
• Device Model Number: VTICMO13.2
• Other Device ID Number: DIOPTER UNK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/10/2015
• Initial Date FDA Received: 08/03/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/27/2016; 02/14/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/11/2015
• 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
• Treatment: CARTRIDGE MODEL AND LOT NUMBER UNK
• Patient Outcome(s): Required Intervention