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

Model Number	MICL 13.7
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Optical Problem (3001); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Visual Disturbances (2140); No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No similar complaint type events were reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.2mm, micl13.2, -11.5 diopter, implantable collamer lens into patient's eye on (b)(6) 2019.Reportedly the surgeon "will determine if the lens needs to be exchanged due to vault".Lens remains implanted."there are no complications with patient as of now." 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
Additional informaiton; serial# updated from serial number (b)(4) to serial number (b)(4).Expiration date updated from 31-aug-2020 to 31-jul-2019.Unique identifier (udi)# updated from (b)(4) to (b)(4).Device manufacture date updated from 14-sep-2018 to 11-aug-2017.(b)(4).
Additional Manufacturer Narrative
The reporter indicated that the surgeon implanted a 13.7mm micl13.7 implantable collamer lens of -11.5 diopter into the patient's left eye (os) on (b)(6) 2019.There is concern for assessment of vaulting and the surgeon will monitor to determine if an exchange is necessary.The patient is doing well with mild complaints of glare.The lens remains implanted.Micl 13.7 should be added to previous mdr.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: 8447848
• Report Number: 2023826-2019-00480
• Device Sequence Number: 355036
• Product Code: MTA
• UDI-Device Identifier: 00841542103329
• UDI-Public: 00841542103329
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: MICL 13.7
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/26/2019
• Supplement Date Received by Manufacturer: 05/21/2019; 06/25/2019
• Initial Report FDA Received Date: 03/25/2019
• Supplement Report FDA Received Date: 06/04/2019; 07/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1