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

Model Number VICM5_12.1

Device Problems Off-Label Use (1494); Contamination /Decontamination Problem (2895)

Patient Problem No Patient Involvement (2645)

Event Date 04/22/2019

Event Type  malfunction  

Manufacturer Narrative

Product manufactured but not sold in the u.S.(b)(4).No similar complaint type events reported for units within the same lot.(b)(4).

Event Description

The reporter indicated that as the surgeon was preparing to implant a 12.1mm vicm5_12.1 implantable collamer lens, -12.0 diopter into the patient's left eye (os), it was discovered to have a foreign body adhesion.As the surgeon checked the lens before the surgery, he found a tiny "plastic debris" on the lens.He washed the lens out with bss and implanted it.The lens remains implanted.This occurred on (b)(6) 2019.

Manufacturer Narrative

(b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 8710344
• MDR Text Key: 148414787
• Report Number: 2023826-2019-01098
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: VICM5_12.1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/24/2019
• Initial Date FDA Received: 06/18/2019
• Supplement Dates Manufacturer Received: 07/30/2019
• Supplement Dates FDA Received: 08/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 21 YR