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

Model Number	TMICL13.2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight: unk.Ethnicity: unk.Race: unk.(b)(4).Work order search: no similar complaint type events were reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that he attempted to insert a13.2mm, tmicl13.2, -13.00/2.00/092 (sphere/cylinder/axis) into the patients right eye (od) two times and then switched to the backup lens.The reporter stated " when i initially tried to insert the icl, it was not gliding through the incision and unfolding properly.I thought that may be due to my incision being too small so i then i enlarged my incision slightly.When i tried to insert the icl again the plunger stuck to the icl, i didn't know if it was an issue with the icl, plunger, cartridge, or injector so i switched everything out in order to ensure i had an icl with proper integrity for the patient." the icl touched the patients eye but was never fully inserted into the patients eye.It was only partially inserted.The backup lens was used with no complications.
Additional Manufacturer Narrative
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: 9362222
• Report Number: 2023826-2019-02182
• Device Sequence Number: 2432154
• Product Code: QCB
• UDI-Device Identifier: 00841542109451
• UDI-Public: 00841542109451
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: TMICL13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/25/2019
• Supplement Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 11/22/2019
• Supplement Report FDA Received Date: 01/16/2020
• 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; CARTRIDGE MODEL: SFC-45 W/FTP, LOT# UNK; FOAM TIP PLUNGER MODEL-FTP, LOT#-UNK; FOAM TIP PLUNGER, LOT# UNK; INJECTOR MODEL-MSI-PF, LOT#-UNK; INJECTOR MODEL: MSI-PF, LOT # UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 24 YR