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

Model Number	MICL 13.7 -12.5
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Claim# (b)(4).
Event or Problem Description
The doctor indicated that he implanted a 13.7 mm micl13.7, -12.5 diopter, implantable collamer lens into the patients right eye (od) on (b)(6) 2018.On (b)(6) 2018 the lens was removed.It was reported that the lens was exchange 3d and the problem was resolved.
Additional Manufacturer Narrative
Corrected data: the reporter indicated that the surgeon implanted a 13.7 mm micl13.7, -12.5 diopter, implantable collamer lens into the patient's right eye (od) on (b)(6) 2018.On (b)(6) 2018 the lens was explanted due to excessive vault and a significant reduction of irido-corneal angle.In a different surgery on (b)(6) 2018 the surgeon implanted a lens of shorter length and the problem was resolved and the patient is happy.The reporter said the cause of the event was "sizing recommendation were not accurate".Claim# (b)(4).
Additional Manufacturer Narrative
Additional information was received.The reporter did not indicate significant reduction of irido-corneal angles and sizing recommendation were not accurate in initial report.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: 7868380
• Report Number: 2023826-2018-01246
• Device Sequence Number: 1567676
• Product Code: MTA
• UDI-Device Identifier: 00841542103619
• UDI-Public: 00841542103619
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/14/2018

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: MICL 13.7 -12.5
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/14/2018
• Supplement Date Received by Manufacturer: 09/19/2018; 11/02/2018
• Initial Report FDA Received Date: 09/12/2018
• Supplement Report FDA Received Date: 10/10/2018; 11/12/2018
• 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
• Patient Age: 34 YR