MAUDE Adverse Event Report: LENSTEC BARBADOS INC. SOFTEC 1; INTRAOCULAR LENS- SOFTEC 1

Model Number SOFTEC 1

Device Problem Difficult to Insert (1316)

Patient Problem Capsular Bag Tear (2639)

Event Date 11/11/2014

Event Type  Injury  

Event Description

Posterior capsule ruptured during insertion.Patient contact, no patient injury, incision enlarged.No information provided as to what inserter or cartridge was used to verify compatability.

Manufacturer Narrative

Additional information relating to the cause of the posterior capsular tear and the instruments used was requested on the (b)(6) 2015.This information was not provided after repeated attempts.After thorough investigation of the lens by the quality systems department, the results are as follows.The lens was returned dry in the vial.The outer pouch, instructions for use, label set and id card were absent from the outer box.A visual inspection was performed at x30 magnification using a stereoscopic microscope.The lens carried a jagged break which passed through the optic; this break appeared to have been made by a sharp instrument during removal of the lens from the eye.The optic also carried a small gouge mark on the optic; this also appeared to have been made by a sharp instrument, possibly during incorrect handling of the device.No foreign material was seen on the iol or in the vial and no further damage was seen on the lens.A full audit of all batch documentation relating to the production of the lens was performed.The audit concluded that all procedures in manufacturing and packaging of the lens had been conducted correctly.Batch reconciliation was 100.0%.Based on the assessment of our batch documentation, lenstec can confirm that all procedures in the manufacturing and packaging of the lens were conducted correctly.Based on the investigation, the break through the optic appeared to have been made by a sharp instrument in order to facilitate removal of the lens from the eye.The small gouge appeared to have also been made by a sharp instrument, possibly during incorrect handling of the device.There was no evidence to suggest that any aspect of the lens was responsible for the surgical complication reported.Additionally, lenstec believes that the lens, its design and the manufacturing process are not at fault due to the extensive testing that we have performed on this model.

Manufacturer Narrative

Additional information relating to the cause of the posterior capsular tear and the instruments used was requested on the 12th february 2015.This information was not provided after repeated attempts.After thorough investigation of the lens by the quality systems department, the results are as follows.The lens was returned dry in the vial.The outer pouch, instructions for use, label set and id card were absent from the outer box.A visual inspection was performed at x30 magnification using a stereoscopic microscope.The lens carried a jagged break which passed through the optic; this break appeared to have been made by a sharp instrument during removal of the lens from the eye.The optic also carried a small gouge mark on the optic; this also appeared to have been made by a sharp instrument, possibly during incorrect handling of the device.No foreign material was seen on the iol or in the vial and no further damage was seen on the lens.A full audit of all batch documentation relating to the production of the lens was performed.The audit concluded that all procedures in manufacturing and packaging of the lens had been conducted correctly.Batch reconciliation was 100.0%.Based on the assessment of our batch documentation, lenstec can confirm that all procedures in the manufacturing and packaging of the lens were conducted correctly.Based on the investigation, the break through the optic appeared to have been made by a sharp instrument in order to facilitate removal of the lens from the eye.The small gouge appeared to have also been made by a sharp instrument, possibly during incorrect handling of the device.There was no evidence to suggest that any aspect of the lens was responsible for the surgical complication reported.Additionally, lenstec believes that the lens, its design and the manufacturing process are not at fault due to the extensive testing that we have performed on this model.Additionally, after discussion the implanting physician indicates that the iol and insertion device were not associated with occurrence.

• Brand Name: SOFTEC 1
• Type of Device: INTRAOCULAR LENS- SOFTEC 1
• Manufacturer (Section D): LENSTEC BARBADOS INC.; airport commercial centre; pilgrim road; christ church 17092 ; BB
• Manufacturer (Section G): LENSTEC BARBADOS INC.; airport commercial centre; pilgrim road; christ church 17092 ; BB
• Manufacturer Contact: jimmy chacko ; 1765 commerce ave n; st. petersburg, FL 33716 ; 7275712272
• MDR Report Key: 4573324
• MDR Text Key: 5561013
• Report Number: 9613160-2015-00003
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P090022/S001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/04/2015

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?: No
• Device Operator: Physician
• Device Expiration Date: 07/11/2019
• Device Model Number: SOFTEC 1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/05/2015
• Initial Date FDA Received: 03/05/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 61 YR