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

Model Number	MICL12.6
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); No Code Available (3191)
Date of Event	12/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Work order search: no similar complaint type events were reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that the surgery implanted a micl12.6, -11.0 diopter, implantable collamer lens in the patient's right eye (od) on (b)(6) 2017.On (b)(6) 2017, the lens was explanted due to the lens being too big.The lens was exchanged for shorter lens.Attempts to obtain additional information have been unsuccessful.
Additional Manufacturer Narrative
Device evaluation: the lens was returned in a vial taped to purchase returned form.Visual inspection found the haptic torn and the lens missing a piece of haptic and optic.(b)(4).
Additional Manufacturer Narrative
Additional data: date of birth: (b)(6).Gender: female.Date of event: (b)(6) 2017.The reporter indicated that the surgeon implanted a micl12.6 implantable collamer lens of -11.0 diopter in the patient's right eye (od) on (b)(6) 2017.On (b)(6) 2017 the lens was exchanged for a shorter lens due to excessive vault and elevated iop assessed on (b)(6) 2017.(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: 7197904
• Report Number: 2023826-2018-00068
• Device Sequence Number: 11124688
• Product Code: MTA
• UDI-Device Identifier: 00841542103046
• UDI-Public: 00841542103046
• 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: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/19/2017

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: Physician
• Device Expiration Date: 04/30/2019
• Device Model Number: MICL12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/19/2017
• Supplement Date Received by Manufacturer: 01/19/2018; 05/16/2018
• Initial Report FDA Received Date: 01/16/2018
• Supplement Report FDA Received Date: 02/13/2018; 06/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 32 YR