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

Model Number	MICL 13.7
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The reporter indicated that a 13.7mm, micl13.7, -11.5 diopter, implantable collamer lens was implanted into the patients left eye (os) on (b)(6) 2020.It was noted that one footplate was not positioned behind the iris during the initial implantation.Secondary surgical intervention was performed on (b)(6) 2020 to position the footplate and the problem was resolved.The reporter stated " it was not a defect of the iol".In the reporters opinion the cause of this event was due to the surgeon not recognizing that the footplate/haptic was out of position.
Additional Manufacturer Narrative
Corrected data: h6/h10 - patient code 3191: secondary surgical intervention (repositioning), "respositioning" should have been specified in initial medwatch 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
• MDR Report Key: 9844756
• Report Number: 2023826-2020-00573
• Device Sequence Number: 11484504
• Product Code: MTA
• UDI-Device Identifier: 00841542103596
• UDI-Public: 00841542103596
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2020

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: 04/30/2020
• 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: 02/19/2020
• Supplement Date Received by Manufacturer: 09/15/2020
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 09/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL: SFC-45 W/FTP, LOT # UNK; INJECTOR MODEL: MSI-TF, LOT # UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 10 YR