MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC CATALYS SYSTEM; OPHTHALMIC FEMTOSECOND LASER

Model Number UNKNOWN CATALYS SYSTEM

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

Patient Problems Retinal Detachment (2047); Visual Impairment (2138); Vitreous Detachment (2445)

Event Date 06/29/2022

Event Type  Injury  

Manufacturer Narrative

Section b3: date of event: exact dates not provided.Used date of article publication as date of event.Section d4: model number: unknown, information not provided.Section d4: a complete catalog number is unknown as the serial number was not provided.Section d4: serial number: unknown, information not provided.Section d4: udi number: a complete udi number is unknown, as the serial number was not provided.Section e1: info not available from the article.Device evaluation: the product testing could not be performed.The reported complaint cannot be confirmed.Manufacturing record evaluation: the manufacturing record review could not be performed because the serial number of the complaint product is unknown.Since the serial number is unknown, the complaint history review could not be performed.Conclusion: since the sample of the complaint product was not returned, and serial number is unknown, it is not possible to determine a malfunction and/or product quality deficiency.Section h4: device manufacture date: unknown, as the serial number was not provided.Citation: subhendu kumar bora, deepak agarwa, ayan mohanta, rhegmatogenous retinal detachment following femtosecond laser-assisted cataract surgery, (2022), oman j ophthalmol; 15 & 2: pp 215-217 all pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

The following article was received based on a literature review: rhegmatogenous retinal detachment following femtosecond laser-assisted cataract surgery article: a case report was done to describe the first case of rhegmatogenous retinal detachment (rrd) following femtosecond laser-assisted cataract surgery (flacs).A 29-year-old male underwent refractive lens exchange in both eyes for high myopia using flacs 3 months ago using catalys (abbott/optimedica) and was implanted with the tecnis 1 aspheric monofocal intraocular lens (iol).On examination, left eye showed macula-off superior bullous rhegmatogenous retinal detachment with posterior vitreous detachment (pvd) manifested by complaints of severe dimness of vision in the left eye for 2 days (perception of light) with an intraocular pressure (iop) of 9mmhg.A 25-gauge vitrectomy was performed in the left eye as treatment.

• Brand Name: CATALYS SYSTEM
• Type of Device: OPHTHALMIC 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: 17344535
• MDR Text Key: 319393939
• Report Number: 3012236936-2023-01832
• Device Sequence Number: 1
• Product Code: OOE
• UDI-Public: (01)
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K113479
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN CATALYS SYSTEM
• Device Catalogue Number: UNK-CATALYS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/27/2023
• 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
• Patient Age: 29 YR
• Patient Sex: Male