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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Deposits (1809); Inflammation (1932); Intraocular Pressure Increased (1937); Vomiting (2144); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Weight: unk.Race: unk.Ethnicity: unk.Date of event: unk.Expiration date unk.Explanted: na.This product is manufactured in the u.S.But not marketed in the u.S.Manufacturer date: unk.(b)(4).Claim # (b)(4).

Event Description

The reporter indicated the surgeon implanted an icl implantable collamer lens, in the patient's right eye (od), in (b)(6) 2008.At post-op 3 hours, the patient had severe nausea and vomiting, but no eye pain.The intraocular pressure was elevated.Post-op there was anterior chamber inflammation and appearance of diffuse whitish precipitates on the anterior surface of the crystalline lens, hypotony and mid-dilated mildly reactive pupil.With administration of topical and systemic steroids, the anterior chamber reaction subsided, and the anterior capsular deposits gradually resolved peripherally with some remaining centrally over the course of several weeks.The patient's visual acuity at 6 months was 20/20.The lens remains implanted.The cause of the event was due to retained viscoelastic in the eye, use of myostat and some iris manipulation in a hyperopic patient.The event was not due to the icl lens.

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia, ca
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia, ca
• Manufacturer Contact: cynthia thai ; 1911 walker avenue; monrovia, ca ; 3037902237
• MDR Report Key: 9759552
• MDR Text Key: 183428139
• Report Number: 2023826-2020-00316
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: LE
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/30/2020

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2020
• Initial Date FDA Received: 02/26/2020
• 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: 23 YR