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

Model Number	TMICL13.2
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient involvement.(b)(4).
Event or Problem Description
The reporter indicated that after opening the vial and placing onto the cartridge, the surgeon noted that a 13.2mm tmicl13.2 implantable collamer lens, -10.0/+1.0/069 (sphere/cylinder/axis) had a "scratch" on it.This occurred on (b)(6) 2019 and there was no patient contact with this lens.A back up lens was then used.
Additional Manufacturer Narrative
Lens work order search - no additional similar complaint type events within associated lots were found.Claim#: (b)(4).
Additional Manufacturer Narrative
Device evaluation: the lens was returned dry in a cartridge case.There was clear surgical residue on the lens surface.Visual inspection found no visible damage to 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 91016
• MDR Report Key: 8912823
• Report Number: 2023826-2019-01502
• Device Sequence Number: 13584777
• Product Code: QCB
• UDI-Device Identifier: 00841542109017
• UDI-Public: 00841542109017
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/29/2019

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: 08/07/2019
• Initial Date Received by Manufacturer: 07/29/2019
• Supplement Date Received by Manufacturer: 09/03/2019; 10/16/2019
• Initial Report FDA Received Date: 08/20/2019
• Supplement Report FDA Received Date: 09/25/2019; 10/17/2019
• 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