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

Model Number	MICL13.2
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/17/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation: lens was returned dry, in a specimen cup.Visual inspection found the lens with the optic torn and black residue that looks like mold on the lens surface.(b)(4).Work order search: no similar claims were reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter stated that the surgeon implanted a micl13.2, -8.0 diopter, implantable collamer lens and explanted it due to incorrect sizing.The reporter stated the icl vault is creating the patient to go into angle closure and indicated the patient had excessive vault.The surgeon performed surgical pi's for each eye which did not remedy the situation.The white to white was remeasured and a secondary surgery was performed on (b)(6) 2017 to exchange the lens for a smaller one.
Additional Manufacturer Narrative
(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: 6400864
• Report Number: 2023826-2017-00350
• Device Sequence Number: 1377997
• Product Code: MTA
• UDI-Device Identifier: 00841542103251
• UDI-Public: (01)00841542103251(17)170531
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 05/31/2017
• Device Model Number: MICL13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/10/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/13/2017
• Supplement Report FDA Received Date: 05/09/2017
• 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 AND LOT # - UNK; INJECTOR MODEL AND LOT # - UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 43 YR