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

Model Number TMICL13.2

Device Problems Improper or Incorrect Procedure or Method (2017); Ejection Problem (4009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/15/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: the lens was returned in liquid, in the lens vial.Visual inspection found the haptic torn.Lens work order search: one similar complaint type event reported for units within the same lot.(b)(4).

Event Description

The reporter indicated that as the surgeon was attempting to implant a 13.2mm tmicl13.2 implantable collamer lens, -8.5/+3.0/092 (sphere/cylinder/axis) into the patient's right eye (od), the lens tore.There was patient contact with the lens, which was removed intraoperatively on (b)(6) 2019.Lens was not fully implanted.Reportedly, the surgeon was not advancing the icl to the tip of the cartridge.When he pushed the plunger down the barrel, it overrode the icl and trapped the trailing haptics in the tip of the cartridge, taking a "bite" out of the icl.An alternate lens was successfully implanted on (b)(6) 2019.There was no patient injury.Reference mfr report# 2023826-2019-00379 for primary lens.

Manufacturer Narrative

Claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS
• Type of Device: PHAKIC TORIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 8409312
• MDR Text Key: 138435554
• Report Number: 2023826-2019-00383
• Device Sequence Number: 1
• Product Code: QCB
• UDI-Device Identifier: 00841542108843
• UDI-Public: 00841542108843
• Combination Product (y/n): N
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/15/2019

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: 09/30/2020
• Device Model Number: TMICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2019
• Initial Date Manufacturer Received: 02/15/2019
• Initial Date FDA Received: 03/11/2019
• Supplement Dates Manufacturer Received: 03/13/2019
• Supplement Dates FDA Received: 03/18/2019
• 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-PF, LOT#-UNK; CARTRIDGE MODEL-SFC-45, LOT#-UNK; FOAM TIP PLUNGER MODEL-FTP, LOT#-UNK; INJECTOR MODEL-MSI-PF, LOT#-UNK
• Patient Age: 34 YR