MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. SMARTLOAD; INTRAOCULAR LENS

Model Number GCB00

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Eye Injury (1845)

Event Date 01/11/2023

Event Type  malfunction  

Manufacturer Narrative

Age, weight and ethnicity: information unknown/ not provided.Per regulation eu (b)(4)(general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Model #: a complete model# is unknown, as product serial number was not provided.Serial#: unknown/ not provided.Catalogue#: a complete catalogue # is unknown, as product serial number was not provided.Expiration date: unknown as product serial number was not provided.Udi #: unknown as product serial number was not provided.Implant date: unknown/ not provided.Explant date: n/a, lens remains implanted, therefor not explanted.The intraocular lens (iol) was not returned for evaluation as it remains implanted.Therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device could not be done since the product identification was not provided.Attempts have been made to obtain missing information.However, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that after implantation, the haptics were attached to each other very tightly and the surgeon had to use forceps to unfold the lens.This is when one haptic twisted towards the anterior chamber and scratched the iris.The lens was manipulated back to bag and the operation finished normally.Through follow-up we learned that when the other haptic opened it turned the lens vertically and the other haptic scratched the edge of the iris and caused minor blood leakage into the anterior chamber.The leak settled by itself and blood was flushed out of chamber.There was no need to remove the lens.The patient recovered fully and the incident did not have any affect on the outcome.No further information was provided.

• Brand Name: SMARTLOAD
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 16309948
• MDR Text Key: 308971021
• Report Number: 3012236936-2023-00194
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Public: (01)
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GCB00
• Device Catalogue Number: GCB00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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