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

Model Number	TMICL13.2
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Ejection Problem (4009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the lens was returned in liquid, in the lens vial.Visual inspection found the optic torn.Lens work order search: one similar complaint type event reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that as the surgeon was attempting to implant a 13.2mm tmicl13.2 implantable collamer lens, -8.5/+3.0/090 (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# 2023826-2019-00383 for back-up lens.
Additional Manufacturer Narrative
Original mdr should be corrected to "visual inspection found the haptic torn." claim#: (b)(4).
Additional Manufacturer Narrative
Claim#: (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS
• Common Device Name: PHAKIC TORIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 8409335
• Report Number: 2023826-2019-00379
• Device Sequence Number: 16203137
• Product Code: QCB
• UDI-Device Identifier: 00841542108843
• UDI-Public: 00841542108843
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 02/15/2019
• Supplement Date Received by Manufacturer: 03/13/2019; 06/03/2019
• Initial Report FDA Received Date: 03/11/2019
• Supplement Report FDA Received Date: 03/18/2019; 06/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 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