MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC UNK_INTRALASE_FEMTOSECOND LASER

Model Number UNK-INTRALASE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Visual Disturbances (2140); Insufficient Information (4580)

Event Date 02/16/2021

Event Type  Injury  

Event Description

The following article was received based on a literature review: article: three-year outcomes of implantable collamer lens followed by excimer laser enhancement ("bioptics") in the treatment of high myopic astigmatism.A retrospective study was done to describe three-year outcomes of spherical implantable collamer lens (icl) followed by excimer laser enhancement (bioptics) in eyes with high myopic astigmatism.A total of 34 eyes of 17 patients underwent icl implantation followed by excimer laser enhancement.During the excimer laser enhancement, the lasik flap creation was done with the intralase fs laser platform (j&j surgical vision) with a 9.2 mm diameter and a 120mm thickness with a superior hinge.It was reported that two eyes were over corrected (n=2) and one eye was under corrected (n=1).There were no identifiable causes that explained these refractive surprises.Residual astigmatism of less than 0.50 d was reported in 88% of eyes.Between 12 months and 3 years, 10% had manifest spherical equivalent (mse) fluctuation greater than 0.50 d.The mean preoperative endothelial cell density (ecd) was 3046 ± 212 cells/mm2 and decreased to 2871 ± 312 cells/mm2 (2062 to 3485) at 12 months post-enhancement.The mean percentage of endothelial cell loss was 5.7% at 12 months post-enhancement.The rms of total higher order aberrations (hoa) was slightly increased at 12-month post-enhancement (from 0.31 ± 0.07 um (0.28 to 0.46) it increased to 0.42 ± 0.18 um (0.20 to 0.66)).Six eyes developed mild night glare (n=6) following enhancement and were started on brimonidine drops with improvement in symptoms.One eye was found to have a steep vault (n=1), and one eye had a shallow vault (n=1) that both warranted icl exchange.Three patients developed trace anterior subcapsular cataract (n=3) that did not affect vision and were observed.One eye developed a rhegmatogenous retinal detachment (n=1) three years after surgery that was treated with a scleral buckle with resulting myopic refraction of -2.00 d.Further interventions were not reported.Other jnj products were mentioned but no complaints were reported against them.

Manufacturer Narrative

Patient age, weight and ethnicity: unknown/not provided.Date of publication used as date of event: 16 february 2021.Serial number, model number: information unknown / not provided.Model: unknown, as the serial number was not provided.Udi number: a complete udi number is unknown, as the serial number was not provided.The device was not available for evaluation.The serial number for the device was not provided; therefore, no further investigation can be performed.If there is any further relevant information received, a supplemental medwatch will be filed.Device manufacture date: unknown, as the serial number was not provided.Citation: samir jabbour and kraig s bower, article: three-year outcomes of implantable collamer lens followed by excimer laser enhancement ("bioptics") in the treatment of high myopic astigmatism clinical ophthalmology 2021:15 635¿643.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: UNK_INTRALASE_FEMTOSECOND LASER
• Type of Device: FEMTOSECOND LASER
• Manufacturer (Section D): AMO MANUFACTURING USA, LLC; 510 cottonwood drive; milpitas CA 95035
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 14610732
• MDR Text Key: 293441548
• Report Number: 3012236936-2022-01492
• Device Sequence Number: 1
• Product Code: HNO
• UDI-Public: (01)
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-INTRALASE
• Device Catalogue Number: UNK-INTRALASE
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention