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

Model Number	MICL12.6
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Unintended Movement (3026)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).No similar complaint type events reported for units within the same lot.(b)(4).
Event or Problem Description
A 12.6mm micl12.6 implantable collamer lens, -9.0 diopter, was implanted into the patient's right (od) eye on (b)(6) 2019.On (b)(6) 2019, the lens was explanted, the surgeon reporting low vault, significant reduction of irido-corneal angles (ica), and that the lens was implanted inverted.On (b)(6) 2019 a longer lens was implanted and the problem is noted as resolved.Surgeon states the patient is "doing well." the cause of the event is reported as device, states the lens "flip[pped] during insertion.".
Additional Manufacturer Narrative
H3-device evaluation: the lens was returned in liquid, in the lens vial.Visual inspection found that the haptic was torn.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 91016
• MDR Report Key: 8795453
• Report Number: 2023826-2019-01232
• Device Sequence Number: 1832509
• Product Code: MTA
• UDI-Device Identifier: 00841542103008
• UDI-Public: 00841542103008
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: MICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2020
• Initial Date Received by Manufacturer: 06/21/2019
• Supplement Date Received by Manufacturer: 01/03/2020
• Initial Report FDA Received Date: 07/16/2019
• Supplement Report FDA Received Date: 01/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL-SFC-45, LOT#-UNK; FOAM TIP PLUNGER MODEL-FTP, LOT#-UNK; INJECTOR MODEL-MSI-TF, LOT#-UNK; CARTRIDGE MODEL-SFC-45, LOT#-UNK; FOAM TIP PLUNGER MODEL-FTP, LOT#-UNK; INJECTOR MODEL-MSI-TF, LOT#-UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 29 YR