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

Model Number MICL13.7

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Hyphema (1911); Hypopyon (1913); Inflammation (1932); Irritation (1941); Pain (1994); Visual Impairment (2138)

Event Date 09/01/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Method - (process evaluation): lens work order search, cartridge lot number search, foam tip plunger lot number search, device history record review.Results - (evaluation result): a lens work order search was performed and no similar complaints were found within the work order.A cartridge lot number search was performed and no similar complaints were found.A foam tip plunger lot number search was performed and no similar complaints were found.A review of the device history record was performed and nothing was found in the manufacturing, sterilization and packaging processes of the lens, injector and cartridge that was likely to have contributed to the complaint.Conclusion - (unable to confirm complaint): based on the complaint history, lens work order search, cartridge and foam tip plunger lot number searches and the device history record review, a specific root cause of the event could not be determined.(b)(4): lens implanted.

Event Description

The reporter stated the surgeon implanted a 13.7mm micl13.7 implantable collamer lens, -11.0 diopter, in the patient's left eye (os) on (b)(6) 2015.The reporter stated at one day post-op ((b)(6) 2015), the patient's eye had hyphema and hypophon.Medications were administered for inflammation but the reporter stated it looked more like an irritated iris.The patient was in pain and cultures were taken.The lens vault is good.The patient returned for a follow-up visit on (b)(6) 2015 and the va was 20/20, there is still some cell in the eye and the vision is not as clear.The reporter stated the test on the culture came back as toxic anterior segment syndrome.The reporter stated the patient's eye has settled down and is recovering.The patient's va was 20/20.

Manufacturer Narrative

(b)(4).Results: per medical review - endophthalmitis is a painful infection of ocular tissues that may occur postoperatively.Unless it is viral in origin, a culture will usually be positive.Toxic anterior segment syndrome (tass) is a painless inflammatory postoperative condition that has been associated with drugs, devices, and surgical issues.Culture is usually negative.It is not clear which of these conditions developed in the patient's eye, and the cause of either condition in this case is unknown.Conclusion: based on the complaint history, work order search, cartridge and foam tip plunger lot number searches, device history record review and medical review, a specific root cause of the event could not be determined.Claim # (b)(4).

• Brand Name: ICL (IMPLANTABLE COLLAMER LENS)
• Type of Device: 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: althea watson ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 5119129
• MDR Text Key: 27297237
• Report Number: 2023826-2015-01262
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 09/01/2015

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: Physician
• Device Expiration Date: 01/31/2016
• Device Model Number: MICL13.7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2014
• 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: 21 YR