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

Lot Number	170129
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	02/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The inspection was performed at 10xmagnification using a stereoscopic microscope.The lens was in two pieces and the cross-sectional inspection revealed a cut.Both pieces of the lens consisted of one half of the optic and an intact haptic, and when fitted together, they formed a complete lens.The lens was clean; no foreign particles were present and no other defects were seen on the lens.The dimension check conducted showed that all measurements were within specification.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 lenses was performed.The audit concluded that all procedures in manufacturing and packaging of the lenses 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 damage on the optic appeared to be a deliberate cut with a sharp instrument, probably 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 instruments used and our results indicate that these devices are compatible.
Event or Problem Description
Lenstec inc received an email stating "loading of the lens went as normal, soaked and used visco.Doctor began to implant the lens, the lens tore the equator of the capsule.".

• Brand Name: SOFTEC I
• 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: 7327946
• Report Number: 9613160-2018-00015
• Device Sequence Number: 109940
• Product Code: HQL
• UDI-Device Identifier: 00844369029483
• UDI-Public: 00844369029483
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P090022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/09/2018

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: 01/26/2022
• Device Lot Number: 170129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2018
• Initial Report FDA Received Date: 03/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1