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

Model Number	TMICL13.2
Medical Device Problem Code	Ejection Problem (4009)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lens work order search: one similar complaint type event reported for units within the same lot.Claim# (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, -15.5/+3.0/089 (sphere/cylinder/axis) into the patient's left eye (os), the footplates of the lens got stuck in the injector.There was no patient contact with the lens.An alternate lens was successfully implanted; "all went well with patient interactions".

• 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: 8453013
• Report Number: 2023826-2019-00487
• Device Sequence Number: 1474259
• Product Code: QCB
• UDI-Device Identifier: 00841542109826
• UDI-Public: 00841542109826
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 03/01/2019

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: 01/31/2021
• Device Model Number: TMICL13.2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2019
• Initial Report FDA Received Date: 03/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 27 YR