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

Model Number	SOFTEC HD
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	06/05/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens was received dry in the vial.The cap was on the vial but the bung was absent.The delivery system was also absent but the outer pouch, instructions for use, label set and id card were enclosed in the outer box.The lens was hydrated and the inspection was performed at x30 magnification using a stereoscopic microscope.The lens was in three pieces with one haptic missing.No foreign material was seen on the lens and the cross-section inspection of the optic areas showed cuts with a sharp instrument.The lens was too badly damaged to carry out dimension testing.The cartridge used was not returned for investigation but the lens model and diopter are compatible with the cartridge.A full audit of all batch documentation relating to the production of the devices was performed.The audit concluded that all procedures in manufacturing and packaging of the devices had been conducted correctly.Batch reconciliation was 100.0%.Based on the batch documentation, lenstec can confirm that all procedures in the manufacturing and packaging of the lens were conducted correctly.Based on the lens inspection, the breaks on the optic appeared to be deliberate cuts with a sharp instrument to facilitate the removal of the lens from the eye.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.Lenstec has also conducted extensive testing on the lens model and the cartridge used and our results indicate that these devices are compatible.
Event or Problem Description
As noted from return goods authorization form; "tear in capsule(bag), vitrectomy done.Lens cut and removed, replaced with a sulcus 3 piece lens.".
Additional Manufacturer Narrative
This is a supplemental report.After follow up contact with user facility it was indicated that the iol and its accessories were unrelated to the vitrectomy.The remainder of the investigation remains as initially reported.Initial report: the lens was received dry in the vial.The cap was on the vial but the bung was absent.The delivery system was also absent but the outer pouch, instructions for use, label set and id card were enclosed in the outer box.The lens was hydrated and the inspection was performed at x30 magnification using a stereoscopic microscope.The lens was in three pieces with one haptic missing.No foreign material was seen on the lens and the cross-section inspection of the optic areas showed cuts with a sharp instrument.The lens was too badly damaged to carry out dimension testing.The cartridge used was not returned for investigation but the lens model and diopter are compatible with the cartridge.A full audit of all batch documentation relating to the production of the devices was performed.The audit concluded that all procedures in manufacturing and packaging of the devices had been conducted correctly.Batch reconciliation was 100.0%.Based on the batch documentation, lenstec can confirm that all procedures in the manufacturing and packaging of the lens were conducted correctly.Based on the lens inspection, the breaks on the optic appeared to be deliberate cuts with a sharp instrument to facilitate the removal of the lens from the eye.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.Lenstec has also conducted extensive testing on the lens model and the cartridge used and our results indicate that these devices are compatible.
Event or Problem Description
This is a supplemental report with additional information about the event as noted from the return goods authorization form; "tear in capsule (bag), vitrectomy done.Lens cut and removed, replaced with a sulcus 3 piece lens.".

• Brand Name: SOFTEC HD
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): LENSTEC BARBADOS INC.; airport commercial centre; pilgrim road; christ church, BB170 92,; BB BB17092,
• MDR Report Key: 6682303
• Report Number: 9613160-2017-00003
• Device Sequence Number: 18878980
• Product Code: HQL
• UDI-Device Identifier: 00844369027366
• UDI-Public: 00844369027366
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P090022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2017

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
• Operator of Device: Physician
• Device Expiration Date: 03/09/2022
• Device Model Number: SOFTEC HD
• Device Lot Number: 170675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/05/2017
• Supplement Date Received by Manufacturer: 06/05/2017
• Initial Report FDA Received Date: 06/30/2017
• Supplement Report FDA Received Date: 08/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1