MAUDE Adverse Event Report: STAAR SURGICAL COMPANY; INTRAOCULAR LENS

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Irritation (1941)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The reporter indicated a nanoflex collamer intraocular lens was implanted in the patient's right eye (od) and the patient appeared to have eye irritation symptoms related to the implant.The reporter indicated it was not an issue with the product but with the patients sensitivity.The lens remains implanted.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch will be submitted.

Manufacturer Narrative

B1 : corrected to product problem.B2 : not applicable.H1 : corrected to malfunction.Claim# (b)(4).

• Brand Name: UNK
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 9293565
• MDR Text Key: 165545521
• Report Number: 2023826-2019-02121
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• PMA/PMN Number: P990013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other