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

Model Number	MICL13.7
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Blurred Vision (2137); No Code Available (3191)
Date of Event	05/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation: lens was returned in liquid, in a specimen cup.Visual inspection found a torn haptic (torn piece missing) and debris on the lens surface.Work order search: a lens work order search was performed.No similar complaints found.(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.7mm, micl13.7, -10.0 diopter, implantable collamer lens into the patient's left eye (os) on (b)(6) 2018.On (b)(6) 2018 the lens was removed and exchanged for a shorter length and different diopter lens due to observation of excessive vault and refractive surprise.This exchange resolved the problem.Progressive myopia was reported as a pre-existing conditions.
Additional Manufacturer Narrative
On (b)(6) 2018 the lens was exchanged for a shorter length and different diopter lens due to observation of excessive vaulting, refractive surprise, and blurred vision.(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: 7597242
• Report Number: 2023826-2018-00900
• Device Sequence Number: 2067369
• Product Code: MTA
• UDI-Device Identifier: 00841542103565
• UDI-Public: 00841542103565
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2018

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: 08/31/2019
• Device Model Number: MICL13.7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/15/2018
• Supplement Date Received by Manufacturer: 08/24/2018
• Initial Report FDA Received Date: 06/13/2018
• Supplement Report FDA Received Date: 08/24/2018
• 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# 1401441; FOAM TIP PLUNGER LOT# 1342348; INJECTOR MODEL: MSI-PF, LOT#: 1371375
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR