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

Model Number	MICL13.2
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	10/25/2018
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 implantable collamer lens, -10.5 diopter, into the patient's eye.The surgeon reports the lens "is too big" and is planning to exchange it for a shorter lens.However, unable to obtain additional information despite repeated requests.
Additional Manufacturer Narrative
Additional information: the lens was implanted in the left (os) eye.On (b)(6) 2018 the lens was exchanged with a shorter lens.The lens was returned in liquid and taped to an email.Visual inspection found no visible damage to the lens.(b)(4).
Additional Manufacturer Narrative
Additional data: lens work order search was performed.One similar complaint type event within associated lots found.(b)(4).
Additional Manufacturer Narrative
Event-updated event statement.Please disregard all previous event statements.Patient codes added.Device code added.Claim #(b)(4).
Event or Problem Description
The reporter indicated that on (b)(6)2018 the surgeon implanted a 13.2mm micl13.2 implantable collamer lens, -10.5 diopter, into the patient's right (od) eye.On (b)(6)2018 the lens was exchanged with a shorter lens due to excessive vault and glare/halos.The problem was resolved.The cause of the event is reported as user error, stating "the implant placed was too big.".

• 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: 8149320
• Report Number: 2023826-2018-01799
• Device Sequence Number: 1498354
• Product Code: MTA
• UDI-Device Identifier: 00841542103305
• UDI-Public: 00841542103305
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/14/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2018
• Initial Date Received by Manufacturer: 11/14/2018
• Supplement Date Received by Manufacturer: 11/20/2018; 12/26/2018; 02/14/2019
• Initial Report FDA Received Date: 12/10/2018
• Supplement Report FDA Received Date: 12/20/2018; 01/22/2019; 02/14/2019
• 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