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

Model Number	MICL12.6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation: the lens was returned in liquid in the vial.Visual inspection of the returned product found no visible damage to the lens.Claim # (b)(4).
Event or Problem Description
Received a 12.6mm micl12.6 implantable collamer lens, -13.0 diopter, from the customer, with no visible damage.The lens was implanted on (b)(6) 2016 and was explanted.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Device evaluation: the lens was returned in liquid in the vial.Visual inspection of the returned product found no visible damage to the lens.Claim # (b)(4).
Additional Manufacturer Narrative
Device available for evaluation?: "returned to manufacturer" date is corrected from 10/11/2016 to 05/31/2017.(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: 6589754
• Report Number: 2023826-2017-00885
• Device Sequence Number: 11021008
• Product Code: MTA
• UDI-Device Identifier: 00841542103084
• UDI-Public: (01)00841542103084(17)170731
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/14/2016

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: 07/31/2017
• Device Model Number: MICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/14/2016
• Supplement Date Received by Manufacturer: Not provided; 08/23/2017
• Initial Report FDA Received Date: 05/24/2017
• Supplement Report FDA Received Date: 06/21/2017; 08/23/2017
• 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