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

Model Number	MICL 13.2 -14.0
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The reporter indicated that the anterior leaflet of a micl13.2, -14.0 diopter, implantable collamer lens tore during loading on (b)(6) 2018, with no patient contact.The backup lens implanted during initial surgery with no patient injury.Problem resolved.
Additional Manufacturer Narrative
Device evaluation: lens was returned in liquid in vial.Visual inspection found the optic torn.Claim# (b)(4).
Additional Manufacturer Narrative
"visual inspection found the optic torn" should be corrected to "visual inspection found the haptic torn" in the previous mdr.(b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 7947525
• Report Number: 2023826-2018-01507
• Device Sequence Number: 1513684
• Product Code: MTA
• UDI-Device Identifier: 00841542103374
• UDI-Public: 00841542103374
• 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: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/11/2018

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: 01/31/2019
• Device Model Number: MICL 13.2 -14.0
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Initial Date Received by Manufacturer: 09/11/2018
• Supplement Date Received by Manufacturer: 11/20/2018; 12/14/2018
• Initial Report FDA Received Date: 10/09/2018
• Supplement Report FDA Received Date: 11/20/2018; 12/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1