MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number DIU150

Device Problems Break (1069); Mechanical Problem (1384); Inaccurate Delivery (2339); Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Age or date of birth, weight, and ethnicity: unknown/ not provided.Date of event: unknown, not provided.Best estimate is (b)(6) 2021.If implanted, give date: not applicable, no patient contact.If explanted, give date: not applicable, no patient contact.Reporter email address: unknown/not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that while being inserted into the patient's eye, a diu150 intraocular lens (iol) misfired, it got stuck in cartridge, then the plunger bypassed the iol.It was learned that there was no patient contact with this device.The doctor felt that the deployment issue could have been due to the thickness of the 8.5 d lens.No other information was provided.

Manufacturer Narrative

Corrected data and additional data: upon further review, it was determined, that the event reported in the initial mdr is no longer reportable, since there was no device malfunction or serious injury that occurred.Nevertheless, product investigation has been completed with the following results.Device evaluation: since product was not received, the complaint issue reported could not be verified.Manufacturing record review: the manufacturing process record was evaluated and revealed, that the product was manufactured and released according to specifications.A search revealed, that no additional complaints were received from this production order.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.

• Brand Name: TECNIS IOL
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• MDR Report Key: 12316800
• MDR Text Key: 266369901
• Report Number: 2648035-2021-08211
• Device Sequence Number: 1
• Product Code: MJP
• UDI-Device Identifier: 05050474746312
• UDI-Public: (01)05050474746312(17)240513
• Combination Product (y/n): N
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/13/2024
• Device Model Number: DIU150
• Device Catalogue Number: DIU150U085
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/14/2021
• Initial Date FDA Received: 08/12/2021
• Supplement Dates Manufacturer Received: 08/13/2021
• Supplement Dates FDA Received: 08/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1MTEC