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

Model Number	MICL 12.6
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Weight: unk, ethnicity: unk, race: unk.No similar complaint type events were reported for units within the same lot.Claim # (b)(4).
Event or Problem Description
The reporter indicated that a 12.6 mm micl 12.6, -12.5 diopter, implantable collamer lens was implanted into the patient's left eye (os) on (b)(6) 2019.Per the reporter, "the lens opened upside down", the lens was removed and back up lens implanted during initial surgery with no patient injury.This resolved the problem.
Additional Manufacturer Narrative
Device evaluation: lens was returned in vial, in liquid.Visual inspection found optic and haptic torn.Claim#: (b)(4).
Additional Manufacturer Narrative
Corrected data: "visual inspection found the optic and haptic torn" should be corrected to "visual inspection found the haptic torn".(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: 8798414
• Report Number: 2023826-2019-01131
• Device Sequence Number: 3027336
• Product Code: MTA
• UDI-Device Identifier: 00841542103077
• UDI-Public: 00841542103077
• 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
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/19/2019

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: 03/31/2020
• Device Model Number: MICL 12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2019
• Initial Date Received by Manufacturer: 06/19/2019
• Supplement Date Received by Manufacturer: 07/24/2019; 09/24/2019
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 07/26/2019; 09/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR