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

Model Number	MICL12.6
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Optical Problem (3001)
Health Effect - Clinical Codes	Visual Disturbances (2140); Halo (2227); No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	11/15/2018
Type of Reportable Event	Serious Injury
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 12.6mm, micl12.6, -11.00 diopter, implantable collamer lens into the patient's right eye (od) on (b)(6) 2018 and excessive vault was observed.The lens remains implanted, surgeon planned to exchanged lens on (b)(6) 2019 but the patient rescheduled surgery.On (b)(6) 2019 is the expected date of surgery.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Additional data: the reporter indicated that the surgeon implanted a 12.6mm, micl12.6, -11.00 diopter, implantable collamer lens into the patients right eye (od) on (b)(6) 2018.On (b)(6) 2019 the lens was exchanged for a shorter length lens due to excessive vault and glare/haloes.This exchange resolved the problem, patient is doing great.Secondary surgical intervention, exchange.Device evaluation: lens was returned in liquid, in a small plastic container.Visual inspection found a torn haptic.Work order search: no similar complaint type events were reported for units within the same lot.Claim # (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: IMPLANTABLE COLLAMER LENS (ICL)
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 8241101
• Report Number: 2023826-2019-00099
• Device Sequence Number: 16691777
• Product Code: MTA
• UDI-Device Identifier: 00841542103046
• UDI-Public: 00841542103046
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: MICL12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2019
• Initial Date Received by Manufacturer: 12/12/2018
• Supplement Date Received by Manufacturer: 02/20/2019
• Initial Report FDA Received Date: 01/11/2019
• Supplement Report FDA Received Date: 02/27/2019
• 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: 30 YR