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 Endophthalmitis (1835); Iritis (1940); Uveitis (2122); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

A case report from the journal of vitreoretinal diseases was received in regard to "culture-negative c acnes endophthalmitis following implantation of a phakic implantable collamer lens".The case report was about a 34-year-old woman who presented with chronic unilateral iritis, with precipitates 5 months after bilateral implantable collamer (icl) implantation in the left eye (os).Treatment with topical prednisolone acetate was initially successful but the iritis recurred.The patient was referred to a uveitis specialist at eight months postop, and tests for uveitis had negative findings.Ultrasound biomicroscopy showed possible chaffing of the iris by the icl.At 10 months after the initial surgery, the icl was removed.Patient continued to develop worsening floaters and va.One year after icl placement, patient had 2+ vitritis with small deposits on posterior surface of natural lens.A diagnostic vitrectomy was performed that was culture negative.Trial of oral prednisone resulted in only transient improvement of uveitis.A second vitrectomy combined with lensectomy was performed.Cultures had negative findings, but bacterial pcr testing was positive for c acnes.Treatment with intravitreal vancomycin and ceftazidime was administered.At 3 months follow-up, patient had complete resolution of ocular inflammation and treatments discontinued.At one-year follow-up patient's vision was 20/20 with correction for aphakia.Additional information has been requested but none has been forthcoming.

Manufacturer Narrative

Weight: unk.Ethnicity: unk.Race: unk.Date of event: unk.Expiration date unk.Implant date: unk.Explant date: unk.Device manufacture date: unk.Health impact- clinical code: (b)(4) precipitates; iris chaffing.Health effect impact code: (b)(4) topical prednisolone acetate.Claim # (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: joselene enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 14365002
• MDR Text Key: 291488987
• Report Number: 2023826-2022-01477
• Device Sequence Number: 1
• Product Code: MTA
• 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: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/11/2022

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: 04/11/2022
• Initial Date FDA Received: 05/11/2022
• 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: 34 YR
• Patient Sex: Female