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

Model Number	MICL 12.6 -7.0
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 12.6 mm micl12.6, -7.0 diopter, implantable collamer lens into the patients left eye (os) on (b)(6) 2018.The lens was exchanged for a shorter length lens due to low vault this exchange resolved the problem.
Additional Manufacturer Narrative
Lens was returned dry, in vial.Visual inspection found no visible damage to lens and residue on lens.(b)(4).
Additional Manufacturer Narrative
Additional information was received.The reporter stated that patient experienced excessive vault and did not experience low vault as initially reported.(b)(4).
Additional Manufacturer Narrative
Corrected data: type of reportable event is malfunction which is corrected from serious injury in the previous mdrs.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: 7799160
• Report Number: 2023826-2018-01245
• Device Sequence Number: 1291231
• Product Code: MTA
• UDI-Device Identifier: 00841542102964
• UDI-Public: 00841542102964
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 07/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: MICL 12.6 -7.0
• 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: 07/26/2018
• Supplement Date Received by Manufacturer: 09/04/2018; 09/14/2018; 10/18/2018
• Initial Report FDA Received Date: 08/20/2018
• Supplement Report FDA Received Date: 09/04/2018; 09/14/2018; 10/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR