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

Model Number UNK-MONOFOCAL

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/17/2023

Event Type  Injury  

Event Description

It was reported that the johnson and johnson (jnj) intraocular lens (iol) was displaced.The serial number is unknown.The displaced iol was exchanged a few weeks ago in a secondary procedure.The replacement lens is ar40e acrylic three-piece iol.The doctor¿s office only had this lens in the particular power.When the customer went to load the replacement iol into the cartridge, it seemed to fit fine but when the customer went to fold the cartridge to put into the injector, the cartridge snapped in half.The symptoms were not due to the breaking of the cartridge.No further information regarding the displaced lens was provided.The event for the cartridge was reported to the fda in mfr# 3012236936-2024-00073.

Manufacturer Narrative

Section d1, brand name: partial information provided due to the unknown serial number.Section d4, model and catalog number: partial information provided due to the unknown serial number.Section d4, expiration date: unknown as the serial number was not provided.Section d4, unique identifier (udi) number: a partial udi was provided as the serial number is not available.Section h4, device manufacture date: unknown as the serial number was not provided.Section h3-other (81): the device was not returned for evaluation as it was discarded.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 will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Section h6-health effect-clinical code: used to capture device decentered or dislocated or tilted subluxated or wrong position.Attempts have been made to obtain the missing information.However, to date, it has not been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Corrected data: through follow-up the customer provided the intraocular lens (iol) serial number (b)(6), the implant date (b)(6) 2023, and incident date (b)(6) 2023.The following field was updated accordingly: section b3, date of event: (b)(6) 2023.Section d4, serial number: (b)(6).Section d6a if implanted; give date: (b)(6) 2023.Additional information: the customer added that the capsule was not stable, so the lens was coming forward.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Corrected data the follow-up report 3012236936-2024-00089 should have included the following information.This current report captures this correction: section d1, brand name: tecnis simplicity.Section d4, model and catalog number: dib00 and dib00u0225 section d4, expiration date: sep 24, 2026.Section d4, unique identifier (udi) number: (b)(4).Section h3: evaluated by manufacturer: yes, based on the serial number as it was received.The product was not received.Section h4, device manufacture date: sep 24, 2023.Additional information evaluation: the serial number was received.Product evaluation was not performed because the product has not been received.A search of complaints related to this production order (po) was performed.The search revealed that no other complaints were received for this po.The complaint issue reported could not be confirmed and no product deficiency or product malfunction could be identified.No nonconformity report, documentation or labeling changes, and further escalations are required.Based on the complaint investigation results, the product was released within specifications.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Corrected data: the initial report 3012236936-2024-00089 should have included the following information.This current report captures this correction: section e1, initial reporter, post office or zip code: (b)(6).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: UNK_MONOFOCAL IOL
• 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: 18493663
• MDR Text Key: 332672760
• Report Number: 3012236936-2024-00089
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Public: (01)
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK-MONOFOCAL
• Device Catalogue Number: UNK-MONOFOCAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/07/2024
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White