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

Model Number	MICL12.6
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	Endophthalmitis (1835); Intraocular Infection (1933); Intraocular Pressure, Delayed, Uncontrolled (1936); Iritis (1940); No Code Available (3191)
Date of Event	02/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation: the lens was returned in a specimen cup.Visual inspection found no visible damage to the lens.(b)(4).Lens work order search: no similar complaint type events reported for units within the same lot.Device history record (dhr) review: based on the results of the investigation, all released devices from the associated work order(s), including the suspected device, have been manufactured within established process parameters; and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 12.6mm micl12.6 implantable collamer lens, -12.0 diopter, into the patient's left eye (os) on (b)(6) 2018.On (b)(6) 2018 the lens was explanted.The surgeon notes acute endophthalmitis with acute iritis.Reportedly, the patient has been treated with an intraocular injection and topical drops including antibiotics.The claim reporter lists the cause of the adverse event as hypotony and wound leakage.No additional information regarding patient's current status is known at this time.
Additional Manufacturer Narrative
Additional data: the reporter stated, "the left eye has improved and is now 20/30-2 with contact lens.No cells were seen in exam with posterior synechaie with slight pigment over anterior lens surface noted on (b)(6) 218 exam." the reporter stated when asked about any idea as to why wound leakage and hypotony had occurred that, "the issue the patient had was due to wound leakage and the patient being a smoker and eye rubber." (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: 7356138
• Report Number: 2023826-2018-00439
• Device Sequence Number: 2023357
• Product Code: MTA
• UDI-Device Identifier: 00841542103060
• UDI-Public: 00841542103060
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2018

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?: No
• Operator of Device: Physician
• Device Expiration Date: 09/30/2019
• Device Model Number: MICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/22/2018
• Supplement Date Received by Manufacturer: 04/11/2018
• Initial Report FDA Received Date: 03/20/2018
• Supplement Report FDA Received Date: 05/04/2018
• 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: 31 YR