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

Device Problems Optical Decentration (1360); Inadequacy of Device Shape and/or Size (1583); Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)

Patient Problems Cataract (1766); Inflammation (1932); Swelling (2091); Blurred Vision (2137); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This product is manufactured in the u.S.But not marketed in the u.S.(b)(4).

Event Description

On 30-jul-2017 staar was made aware of a journal article regarding a case of hypermature cataract formation following implantation of an implantable collamer lens with an aquaport.The article states the patient was a (b)(6) man and a 12.6 mm lens was inserted into his left eye (os) at another (unknown) clinic 4 months previously.The patient complained of blurry vision.Medical records showed no intraoperative surgical complications.Upon examination, the following was noted: anterior subcapsular opacity, swelling of the lens, vaulting of the lens was 1/4 of the corneal thickness, the icl was decentered inferonasally and in a vertical position.It is stated that, after one month, the subcapsular opacity progressed rapidly to a hypermature cataract and the icl was rotated to 60 degrees from the horizonal meridian.There was a flare of 1+ in the anterior chamber.Cataract surgery was performed and the icl was explanted.Upon explantation, the lens showed whitish infiltrates on its surface.The reason for the rapid cataract progression is not clear.Upon contact with 2 of the 3 surgeons who wrote the article, the following information was obtained: this case occurred 3-4 years prior to article publication.The surgeon had a "strong suspicion" that there was a surgical complication on this case and that the lens was touched during the operation however, this could not be proven nor confirmed as the original operation surgeon denied any surgical complication.No additional information is available.

Manufacturer Narrative

(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: michelle andres ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 6828273
• MDR Text Key: 83910843
• Report Number: 2023826-2017-01379
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 29 YR