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

Model Number MICL13.2

Device Problems Inadequacy of Device Shape and/or Size (1583); Appropriate Term/Code Not Available (3191)

Patient Problems Intraocular Pressure Increased (1937); Pupillary Block (2026); Blurred Vision (2137); Prolapse (2475); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Results code(s): (operational problem): visual inspection of the returned product found no visible damage to the lens.The lens was returned in liquid.(b)(4).

Event Description

The reporter stated the surgeon implanted a 13.2mm micl13.2 implantable collamer lens, -10.0 diopter, in the patient's right eye (od) on (b)(6) 2016.The lens was explanted on (b)(6) 2016 due to excessive vaulting, elevated intraocular pressure (pupillary block), narrowing of the angle, angle closure, shallowing of the anterior chamber and iris prolapse.The patient experienced blurred vision.A secondary surgery was performed to laser the peripheral iridotomies and the lens was repositioned but the patient still had pressure issues.The lens was exchanged for a shorter lens.The patient's pupil has remained large with some shallowing of the anterior chamber but the issue has improved.The patient's post-op best-corrected visual acuity was 20/20.

Manufacturer Narrative

Method: (process evaluation): device history record review.Result: (no failure detected): based on the results of the investigation, all released devices from the associated work order(s), including the suspected device, have been manufactured within the established process parameters; and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.Conclusion: (unable to confirm complaint): based on the complaint history, work order search, product evaluation, medical review and device history record review, a specific root cause of the event could not be determined.(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: michelle andres ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 5710842
• MDR Text Key: 47082825
• Report Number: 2023826-2016-00807
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/10/2016

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: 07/31/2017
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/10/2016
• Initial Date FDA Received: 06/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2015
• 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: 32 YR