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

Model Number MICL

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Corneal Edema (1791); Intraocular Pressure Increased (1937); Optical Nerve Damage (1986); Pupillary Block (2026); Blurred Vision (2137); Visual Disturbances (2140); Halo (2227); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/20/2020

Event Type  Injury  

Manufacturer Narrative

Age or dob: unk.Sex: unk.Weight: unk.Ethnicity: unk.Race: unk.Date of event: unk.Common device name: product code: unk; esubmitter software does not allow for blank or unk entry.(expiration date): unk, no serial number reported.Implant date: unk.(device manufacturing date): unk, no serial numbers reported.Claim # 431266.

Event Description

The reporter indicated that an implantable collamer lens was implanted into the patients eye and the patient experienced high vault and high iop (intraocular pressure).Lens remains implanted.Additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.

Manufacturer Narrative

B5:the reporter indicated that a 13.2mm, micl13.2, -5.50 diopter, implantable collamer lens was implanted into the patients right eye (od) on (b)(6) 2020.Excessive vault, pupil block, angle closure with elevated iop (47mmhg), pigment dispersion, glare/haloes and blurred vision was observed.Additional surgical intervention (pis) was performed.The reporter stated "the patient was cyclopleged with atropine for an extended period of time until the iop could be stabilized and the corneal edema improve with steroids, oral and topical iop lowering medications.This took several weeks to resolve".It was reported that the problem resolved, last visit date (b)(6) 2020 (bcva:20/20, ucva:20/20--, vault:1.5ct, iop:12mmhg).For status of the eye (sign/symptoms) the reporter stated "he subsequently developed unexplained symptomatic right sided optic nerve edema and was sent to the er for full neurological and ophthalmological evaluation.Mri was negative except for enhancement of the right optic nerve potentially consistent with optic neuritis.The head neurologist did not feel that it was classic neuritis but he was treated for it regardless".Additional information reported "he was given iv steroids in the hospital and sent home with a few days of high does oral steroids." no other symptoms have developed.In the reporters opinion the cause of this event may have been retained ovd behind the iol causing angle closure and pupillary block.H6- work order search: no similar complaint type events were reported for units within the same lot.(b)(4).

Manufacturer Narrative

Corrected data: b5 - should have been specified that a yag pi was performed.H6 - 4581: angle closure, pigment dispersion, enlargment of pi (yag), should have been specified.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
• MDR Report Key: 11043753
• MDR Text Key: 222698287
• Report Number: 2023826-2020-03159
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/21/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: MICL
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/21/2020
• Initial Date FDA Received: 12/21/2020
• Supplement Dates Manufacturer Received: 12/28/2020; 06/09/2021
• Supplement Dates FDA Received: 01/27/2021; 06/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 26 YR