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

Device Problems Misfocusing (1401); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Endophthalmitis (1835); Inflammation (1932); Pain (1994); Blurred Vision (2137); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

A case report from (b)(6) journal of ophthalmology was received in regard to "chronic postoperative cutibacterium acnes endophthalmitis with implantable collamer lens".The case report was about a (b)(6)-year-old male who presented 3 months after icl implantation of the right eye (od) with blurry vision, redness and ocular pain in the setting of prolonged post-operative anterior chamber (ac) cell.Reduced visual acuity (va) at 20/30-1, keratic precipitates, 1+ ac cell, and white icl precipitates were concerning for chronic post-operative endophthalmitis.Anaerobic cultures from a vitreous tap grew c.Acnes.Multiple intra-vitreal and intracameral injections with topical steroids were required to maintain a stable va at 20/30; however, inflammation persisted and removal of the icl and his native lens was ultimately required.After several months, without recurrence of inflammation, a secondary sulcus iol was placed with resulting uncorrected visual acuity of 20/20.Additional information has been requested but none has been forthcoming.

• 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: 14364864
• MDR Text Key: 291848505
• Report Number: 2023826-2022-01476
• 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: 45 YR
• Patient Sex: Male