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

Model Number	TMICL12.6
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Unintended Movement (3026)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pt info: unk.No similar complaint type events were reported for units within the same lot.Lens was returned in vial, in liquid.Visual inspection found haptic torn.(b)(4).
Event or Problem Description
The reporter indicated that a 12.6mm, tmicl12.6, -7.00/4.0/090 (sphere/cylinder/axis), implantable collamer lens was implanted into the patients left eye (os) on (b)(6) 2018.Lens rotation not associated to low vault was observed, the lens was removed and replaced during inital surgery.The problem was resolved.Cause of the event is reported as user error, unknown, and other; 1st toric icl could not see marks well.It was reported that the initial lens unfolded upside down.
Additional Manufacturer Narrative
Claim#: (b)(4).
Additional Manufacturer Narrative
The reporter indicated that a 12.6mm tmicl12.6 implantable collamer lens of -7.00/4.0/090 (sphere/cylinder/axis) was implanted into the patient's left eye (os) on (b)(6) 2018.It was reported the lens unfolded upside down due to not being able to see the marks well.The lens was removed and replaced during the same initial surgery.The problem was resolved.Device code 2923: previous code not applicable.Claim#: (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC TORIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 8206532
• Report Number: 2023826-2018-01909
• Device Sequence Number: 19375858
• Product Code: QCB
• UDI-Device Identifier: 00841542106481
• UDI-Public: 00841542106481
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/11/2018

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: TMICL12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2018
• Initial Date Received by Manufacturer: 12/11/2018
• Supplement Date Received by Manufacturer: 03/06/2019; 03/14/2019
• Initial Report FDA Received Date: 12/31/2018
• Supplement Report FDA Received Date: 03/06/2019; 03/14/2019
• 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#-1401442; CARTRIDGE#SFC-45,LOT#UNK; FOAM TIP PLUNGER MODEL-FTP, LOT#-1404423; FOAMTIPPLUNGER#FTP,LOT#UNK; INJECTOR MODEL-MSI-PF, LOT#-1390762; INJECTOR#MSI-PF,LOT#UNK; CARTRIDGE#SFC-45,LOT#UNK; FOAMTIPPLUNGER#FTP,LOT#UNK; INJECTOR#MSI-PF,LOT#UNK
• Patient Age: 24 YR