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

Model Number	MICL12.6
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Lens work order search: no similar complaint type events reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that the surgeon planned to exchange a 13.7mm micl13.7, diopter -5.0 implantable collamer lens, on (b)(6) 2017.The surgeon notes "shallow vault." reporter states the lens was exchanged.Attempts to obtain additional information have not been successful.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Reportedly, on (b)(6) 2017 the surgeon implanted a 12.6mm micl implantable collamer lens, -5.0 diopter, into the patient's left eye (os).On (b)(6) 2017, the lens was exchanged with a longer lens due to "large vault post-op." the problem was not resolved, see 2023826-2018-00084 for case resolution.
Additional Manufacturer Narrative
Date of birth - corrected to (b)(6).(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: 7180663
• Report Number: 2023826-2018-00033
• Device Sequence Number: 1301385
• Product Code: MTA
• UDI-Device Identifier: 00841542103466
• UDI-Public: 00841542103466
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/12/2017

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: Physician
• Device Expiration Date: 10/31/2017
• Device Model Number: MICL12.6
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/12/2017
• Supplement Date Received by Manufacturer: 01/12/2018; 02/19/2018
• Initial Report FDA Received Date: 01/10/2018
• Supplement Report FDA Received Date: 02/06/2018; 02/19/2018
• 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: 35 YR