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 Patient Involvement (2645)
Date of Event	10/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lens work order search: no similar complaint type events reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that as the surgeon was loading a 12.6mm tmicl12.6 implantable collamer lens, -12.5/+1.0/092 (sphere/cylinder/axis) it tore.This occurred on (b)(6) 2019 and there was no patient contact with this lens.The cause of the event is reported as unknown and a back-up lens was successfully implanted.
Additional Manufacturer Narrative
H3-device evaluation: the lens was returned dry in a lens vial.There was clear surgical residue on the lens surface.Visual inspection found that the haptic was torn.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: 9612926
• Report Number: 2023826-2020-00149
• Device Sequence Number: 18969484
• Product Code: QCB
• UDI-Device Identifier: 00841542107198
• UDI-Public: 00841542107198
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2019

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: TMICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Initial Date Received by Manufacturer: 12/26/2019
• Supplement Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 01/21/2020
• Supplement Report FDA Received Date: 02/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1