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

Model Number	MICL 13.2 -14.5
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No similar complaint type events were reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that a micl13.2, cc4204a, -14.5 diopter, implantable collamer lens tore during loading.It was reported that there was no patient contact.Cause of event cartridge, model and lot numbers not available.
Additional Manufacturer Narrative
Device evaluation: lens was returned in vial, in liquid.Visual inspection found haptic torn.Lens torn into two pieces.(b)(4).
Additional Manufacturer Narrative
Corrected data: initial report states device is "a micl 13.2, cc4204a, -14.5 diopter"; correct description is "a micl 13.2, -14.5 diopter".(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: 7898353
• Report Number: 2023826-2018-01431
• Device Sequence Number: 16591213
• Product Code: MTA
• UDI-Device Identifier: 00841542103381
• UDI-Public: 00841542103381
• 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: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/22/2018

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: 01/31/2020
• Device Model Number: MICL 13.2 -14.5
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2018
• Initial Date Received by Manufacturer: 08/22/2018
• Supplement Date Received by Manufacturer: 09/26/2018; 11/01/2018
• Initial Report FDA Received Date: 09/21/2018
• Supplement Report FDA Received Date: 10/19/2018; 11/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 35 YR