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

Model Number	MICL13.2
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	08/29/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lens was returned in liquid in the lens vial.Visual inspection found a tear in the haptic.No similar complaint type events reported for units within the same lot.(b)(4).
Event or Problem Description
Reportedly, while preparing to insert a 13.2mm micl13.2, diopter -10.0 implantable collamer lens into the patient's left (os) eye, the lens was damaged.The returned box states the lens was not implanted and "lens removed-was not opening properly." the surgery date is listed as (b)(6) 2017.Attempts to obtain additional information have not been successful.
Additional Manufacturer Narrative
Additional information: surgeon states that when the lens was injected into the eye it did not unfold properly.The lens was in the eye still folded "despite waiting for some time." the lens was implanted, removed, and "ultimately a back-up lens was implanted afterward." (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS
• Common Device Name: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 7006984
• Report Number: 2023826-2017-01692
• Device Sequence Number: 1298468
• Product Code: MTA
• UDI-Device Identifier: 00841542103299
• UDI-Public: 00841542103299
• 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: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2017

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 02/28/2019
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/13/2017
• Supplement Date Received by Manufacturer: 12/01/2017
• Initial Report FDA Received Date: 11/07/2017
• Supplement Report FDA Received Date: 12/20/2017
• 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: 26 YR