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 Codes	Inflammation (1932); Intraocular Pressure Increased (1937)
Date of Event	02/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No similar complaint type events were reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that a 12.6mm.Micl12.6, -6.0 diopter, implantable collamer lens is too large for the patient, increased eye pressure.Will be replacing with a shorter length lens.No patient injury.However, the patient later stated " if there was something wrong the implant would have been removed".Additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Claim#: (b)(4).
Additional Manufacturer Narrative
Doctor is not removing or replacing the current implant.The doctor felt because the view was hazy due to inflammation and pressure the vault size had to be too big, which must be leading to the increase in eye pressure.The patient was monitored for approximately 2-3 months.The patients pressure went down to normal range and vision is 20/20.The vault size is 100%.Pt is very happy with outcome.Patient code:1932 added to initial mdr.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: 8504763
• Report Number: 2023826-2019-00588
• Device Sequence Number: 1501383
• Product Code: MTA
• UDI-Device Identifier: 00841542102940
• UDI-Public: 00841542102940
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/14/2019

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: 04/30/2020
• Device Model Number: MICL12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/14/2019
• Supplement Date Received by Manufacturer: 04/23/2019; 07/15/2019
• Initial Report FDA Received Date: 04/11/2019
• Supplement Report FDA Received Date: 05/23/2019; 07/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR