MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS ITEC PRELOADED 1-PIECE IOL; MONOFOCAL IOLS

Model Number PCB00

Device Problems Difficult or Delayed Positioning (1157); Premature Activation (1484)

Patient Problem No Code Available (3191)

Event Date 07/16/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Age/date of birth: unknown.(b)(4).All pertinent information available to abbott medical optics has been submitted.Placeholder.

Event Description

It was reported that the intraocular lens, (iol) came out fast and compromised the patient's capsule.The iol was explanted (removed) and replaced with an anterior chamber (ac) lens.The suspect lens did not advance properly.Further instruction was provided by in service training.No further information was provided.

Manufacturer Narrative

(b)(4).The intraocular lens (iol) was returned to the manufacturing site for investigation.Visual inspection found the cartridge in the correct position and the lens assembled correctly (fully engaged into lower body of the pcb00 device).Stress marks were visible at the cartridge neck and tip deformation was observed.The returned product verified that the cartridge inside was empty.The iol was observed outside of the cartridge body.During visual inspection, the lens was observed without the presence of cosmetic defects.However, surface residuals (fiber/particles) and ovd (viscoelastic) residue on the lens was found and is compatible with handling of the lens.The observations were identified in an optical lens without damage, and/or on the haptics.The functional test could not be performed because the device is single use and used.The manufacturing records were reviewed.Process record evaluation was performed and the lens manufacturing process record was verified and it was found that the lenses were manufactured within specifications.There were no associated deviations or non-conformity reports found in the manufacturing record review that were related to reported complaint.The lenses were released according specification in compliance with the product intended use as required.The device manufacturing procedures were performed as required.The lens met specification prior to release.All pertinent information available to abbott medical optics has been submitted.

Event Description

Additional information received: the surgeon did say that yes it was necessary to widen the incision.

• Brand Name: TECNIS ITEC PRELOADED 1-PIECE IOL
• Type of Device: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• Manufacturer (Section G): ABBOTT MEDICAL OPTICS INC.; road 402 north, km 4.2; anasco industrial park, pob 14; anasco PR 00610
• Manufacturer Contact: stephanie solomon ; 1700 east st. andrew place; santa ana, CA 92705 ; 7145663731
• MDR Report Key: 4998808
• MDR Text Key: 22805176
• Report Number: 2648035-2015-00613
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Report Date: 09/10/2015

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?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/19/2018
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2015
• 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