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

Model Number MICL12.6

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Endophthalmitis (1835); Intraocular Infection (1933); Intraocular Pressure, Delayed, Uncontrolled (1936); Iritis (1940); No Code Available (3191)

Event Date 02/21/2018

Event Type  Injury  

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 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.

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)
• Type of Device: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: cynthia thai ; 1911 walker avenue; monrovia, CA 91016 ; 8002927902
• MDR Report Key: 7356138
• MDR Text Key: 102995331
• Report Number: 2023826-2018-00439
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00841542103060
• UDI-Public: 00841542103060
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/22/2018
• Initial Date FDA Received: 03/20/2018
• Supplement Dates Manufacturer Received: 04/11/2018
• Supplement Dates FDA Received: 05/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR