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

Model Number	MICL13.2
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, inside of the lens vial.Visual inspection found no visible damage to the lens.(b)(4).Lens work order search: no similar complaint type events reported for units within the same lot.Claim # (b)(4).
Event or Problem Description
A 13.2mm micl13.2 implantable collamer lens, -5.5 diopter, lens was received returned with a note, "explanted lens" on it.Attempts to obtain additional information have not been successful.
Additional Manufacturer Narrative
Corrected: please disregard this mfr report.It was discovered that this claim is linked to mfr# 2023826-2018-01270.The customer returned the explanted lens inside the replacement lens box.The current claim was initiated in error against the replacement lens as the box was not labeled with the correct serial number by the customer.There is no complaint to be initiated against the replacement lens at this time.Claim# (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: 7870377
• Report Number: 2023826-2018-01375
• Device Sequence Number: 19224209
• Product Code: MTA
• UDI-Device Identifier: 00841542103206
• UDI-Public: 00841542103206
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2018

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: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2018
• Initial Date Received by Manufacturer: 08/17/2018
• Supplement Date Received by Manufacturer: 09/12/2018
• Initial Report FDA Received Date: 09/12/2018
• Supplement Report FDA Received Date: 10/08/2018
• 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