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

Model Number	MICL 13.7
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lens was returned in liquid, in lens vial.Visual inspection found one of the haptics torn.No similar complaint type events were reported for units within the same lot.(b)(4).
Event or Problem Description
A 13.7mm, micl13.7, -16.0 diopter, implantable collamer lens was returned back to us damage." not used" was handwritten on the lens packaging box.Additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Corrected data: d10- lens returned to manufacturer date 24-feb-2020 in initial mdr corrected to 30-jan-2020.Claim# (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
• MDR Report Key: 9806038
• Report Number: 2023826-2020-00445
• Device Sequence Number: 643692
• Product Code: MTA
• UDI-Device Identifier: 00841542103688
• UDI-Public: 00841542103688
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 02/12/2020

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: 04/30/2021
• Device Model Number: MICL 13.7
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Initial Date Received by Manufacturer: 02/12/2020
• Supplement Date Received by Manufacturer: 05/28/2020
• Initial Report FDA Received Date: 03/09/2020
• Supplement Report FDA Received Date: 05/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1