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	Cataract (1766); Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Work order search: no similar complaint was reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated the surgeon implanted a12.6mm micl12.6 implantable collamer lens, -10.5 diopter, on (b)(6) 2016.The lens was reported as having a shallow vault.The patient returned for a post-op visit a couple of weeks ago with worsening vision and a lot of haze.The patient had anterior subcapsular cataracts ou, od is worse than os.Od is correctable to 20/25 and os is only superior so not sensitive to cataract quite yet.The patient is not happy with her vision and is being monitored.The lens remains implanted.See mfr.Report # 2023826-2018-01363 for fellow eye.
Additional Manufacturer Narrative
The reporter indicated the surgeon implanted a12.6mm micl12.6 implantable collamer lens, -9.00 diopter, on (b)(6) 2016.The lens was reported as having a shallow vault.The patient returned for a post-op visit a couple of weeks ago with worsening vision and a lot of haze.The patient had anterior subcapsular cataracts ou, od is worse than os.Od is correctable to 20/25 and os is only superior so not sensitive to cataract quite yet.The patient is not happy with her vision and is being monitored.The lens remains implanted.See mfr.Report # 2023826-2018-01363 for fellow eye.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: 7873772
• Report Number: 2023826-2018-01364
• Device Sequence Number: 2488991
• Product Code: MTA
• UDI-Device Identifier: 00841542103008
• UDI-Public: 00841542103008
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2016

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: 05/31/2018
• Device Model Number: MICL12.6
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/16/2018
• Supplement Date Received by Manufacturer: 10/04/2018
• Initial Report FDA Received Date: 09/13/2018
• Supplement Report FDA Received Date: 10/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL SFC-45 - LOT NUMBER UNK; FOAM TIP PLUNGER MODEL FTP - LOT NUMBER UNK; INJECTOR MODEL MSI-PF - LOT NUMBER UNK
• Outcome Attributed to Adverse Event: Other