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

Model Number VICM5_13.2

Device Problems Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017); No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/17/2020

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k): this product is manufactured in the u.S.But not marketed in the u.S.(b)(4).

Event Description

The reporter indicated that a 13.2mm vicm5_13.2 implantable collamer lens, -7.5 diopter had difficulty during injection into the patient's right (od) eye.This occurred on (b)(6) 2020.The lens was not fully implanted and was successfully replaced with a back-up lens.The problem is resolved.The cause of the event is reported as user error.

Manufacturer Narrative

B5-additional information: there was no patient contact with the lens.Reference mfr file# 717760 for replacement lens.Claim# (b)(4).

Manufacturer Narrative

B5 - additional information corrected to "there was patient contact with the lens.Reference mfr file# 717760 for replacement lens." in supplemental mdr#1.Claim#: (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 10722605
• MDR Text Key: 213021791
• Report Number: 2023826-2020-02491
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 09/28/2020

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 Model Number: VICM5_13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/28/2020
• Initial Date FDA Received: 10/22/2020
• Supplement Dates Manufacturer Received: 10/22/2020; 05/04/2021
• Supplement Dates FDA Received: 11/17/2020; 05/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTRIDGE MODEL-SFC-45, LOT#-UNK; FOAM TIP PLUNGER MODEL-FTP, LOT#-UNK; INJECTOR MODEL-MSI-TF, LOT#-UNK
• Patient Age: 21 YR