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

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Cyst(s) (1800); Intraocular Pressure Increased (1937); Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Weight: unk.Ethnicity: unk.Weight: unk.Date of event: unk.Expiration date unk.Implanted: unk.Explanted: na.This product is manufactured in the u.S.But not marketed in the u.S.Device manufacture date: unk.(b)(4).

Event Description

An article was received that cited a case study that found patient implanted with a 12.1mm implantable collamer lens, -6.00 diopter in the patients right eye (od).At one day post-operative, the patient suffered painful eye.The patient had severe corneal edema.Slit-lamp examination showed irido-corneal contact at temporal mid-periphery, shallow anterior chamber with central vaulting of icl, partial obstruction of peripheral iridotomy, intraocular pressure was not measured but the eye was very firm.Oral and systematic antiglaucoma medications including intravenous (iv) mannitol 20% were administered.Additional laser procedure to reopen peripheral iridotomy was performed.An ultrasound biomicroscopy (ubm) showed a temporal posterior iris cyst at 8 o'clock, which was pushing the piol-iris complex forward causing irido-corneal angle closure.Patient was readmitted to surgery for repositioning of the icl.The next day, patient did not complain of severe ocular pain.Corneal edema improved markedly and iop was 20 mmhg.At 1 month follow-up visit, ucva was 0.9 bilaterally.Corneal edema disappeared and iop was 20 mmhg.The lens remained implanted.

• 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 ; 6263037902
• MDR Report Key: 9338922
• MDR Text Key: 167344686
• Report Number: 2023826-2019-02167
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/22/2019
• Initial Date FDA Received: 11/18/2019
• Was Device Evaluated by Manufacturer?: No
• 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: 27 YR