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

Model Number	TMICL12.6
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No similar complaint type events reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that a toric icl 12.6mm tmicl12.6 implantable collamer lens, -14.5/2.0/094 (sphere/cylinder/axis) tore in the injector during surgery on the patient's right eye (od).The lens was implanted and removed intraoperatively on (b)(6) 2020.On a later date an alternate lens was implanted and the problem was resolved.
Additional Manufacturer Narrative
H3 - device evaluation: the lens was returned in liquid in a lens vial with residue on the lens.Visual inspection found the optic and haptic torn as well as residue on the lens.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
• MDR Report Key: 9696241
• Report Number: 2023826-2020-00224
• Device Sequence Number: 2755965
• Product Code: QCB
• UDI-Device Identifier: 00841542107495
• UDI-Public: 00841542107495
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: TMICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2020
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 02/14/2020
• Initial Report FDA Received Date: 02/11/2020
• Supplement Report FDA Received Date: 02/18/2020
• 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 # 1453405; FOAM TIP PLUNGER MODEL- FTP, LOT # 1453820; INJECTOR MODEL-MSI-PF, LOT# 1450941
• Patient Age: 30 YR