MAUDE Adverse Event Report: STAAR SURGICAL CO. COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INRTRAOCU; INTRAOCULAR LENS

Model Number CC4204A

Device Problem Lens, vaulting (1366)

Patient Problems Pain (1994); Visual Disturbances (2140)

Event Date 01/14/2014

Event Type  Injury  

Manufacturer Narrative

Evaluation method: medical review.Results: medical review: os: reportedly intraoperative lens removal/exchange was performed to address surgeon`s inability to properly place the lens in the posterior capsule upon insertion.The most likely cause of the event was patient anatomy issue (too small capsule for the lens size).The reporter stated that lens vaulted due to "tight fit." incision was enlarged for iol removal and another staar lens of different model was implanted successfully.No reported postoperative sequelae.The dfu provides the standard diameter of collamer lens for optic and overall, therefore the event was not lens related in origin.Conclusions - (no conclusion can be drawn): based on the complaint history, work order search, medical review and the evaluation of the returned product,a specific root cause of this event could not be determined.(b)(4).

Event Description

The reporter stated the surgeon implanted a cc4204a collamer single piece lens in the pt's left eye.The lens was placed in the eye, and as the lens was positioned in the capsule, the lens vaulted.There was a tight fit and the pt complained of dull eye pain.The surgeon decided to remove the lens, enlarge the incision and cut the lens to remove.A staar three piece lens with the same diopter 24.0 was implanted.No suture was required.This was during the same procedure.Cause of this event is unk.Reporter stated the pt has diabetic retinopathy.

Manufacturer Narrative

(b)(4).Method: lens work order search.Results: visual inspection of the returned product found the lens in three pieces.The optic and both haptics are torn.Piece of plate haptic and piece of optic torn off and missing.Lens was returned in liquid.A lens work order search was performed and no similar complaint was found within the same work order.Conclusions: based on the complaint history, lens work order search and the evaluation of the returned product, a specific root cause of this event could not be determined.#(b)(4).

Manufacturer Narrative

Method: device history review.Results: device history review - upon review of the device history record and the investigation conducted, a conclusion can be drawn that nothing in the manufacturing and packaging processes contributed to the complaint.No root cause can be identified.Conclusions: based on the complaint history, work order search, medical review, device history review and the evaluation of the returned product, a specific root cause of the event could not be determined.(b)(4).

• Brand Name: COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INRTRAOCU
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL CO.; monrovia CA
• Manufacturer Contact: althea watson ; 1911 walker ave.; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 3672027
• MDR Text Key: 11720445
• Report Number: 2023826-2014-00116
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990013
• 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,Followup
• Report Date: 01/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2014
• Device Model Number: CC4204A
• Other Device ID Number: DIOPTER 24.0
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/29/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2012
• 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: 69 YR