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

Model Number	MICL 13.2 -
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.2mm micl13.2, -8.00 diopter, implantable collamer lens into the patients right eye (od) on (b)(6) 2018.On (b)(6) 2018 the lens was exchanged for a shorter length lens due to excessive vault.This exchange resolved the problem.
Additional Manufacturer Narrative
The reporter indicated that the surgeon implanted a 13.2mm micl13.2 implantable collamer lens of -8.00 diopter into the patient's right eye (od) on (b)(6) 2018.Secondary yag was performed for enlargement of pi.The lens was explanted on (b)(6) 2018 due to excessive vault and a shorter lens was later implanted on the same day in a different surgery.The problem was resolved.(b)(4).
Additional Manufacturer Narrative
Deice evaluation: lens was returned in liquid, in lens vial.Visual inspection found no visible damage to the lens.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: 7824747
• Report Number: 2023826-2018-01291
• Device Sequence Number: 16511219
• Product Code: MTA
• UDI-Device Identifier: 00841542103251
• UDI-Public: 00841542103251
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/31/2018

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: 08/31/2019
• Device Model Number: MICL 13.2 -
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Initial Date Received by Manufacturer: 07/31/2018
• Supplement Date Received by Manufacturer: 09/20/2018; 11/06/2018
• Initial Report FDA Received Date: 08/28/2018
• Supplement Report FDA Received Date: 10/17/2018; 11/06/2018
• 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: 36 YR