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

Model Number PCB00

Device Problems Material Fragmentation (1261); Mechanical Jam (2983)

Patient Problems Eye Injury (1845); Hemorrhage/Bleeding (1888); Blurred Vision (2137); Loss of Vision (2139); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/10/2023

Event Type  Injury  

Manufacturer Narrative

Section a4 and a5: per regulation (b)(4) (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Section d6a: if implanted, give date: not applicable, as lens was removed/replaced in the initial surgery.Section d6b: if explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.Section e1 - telephone number: (b)(6).Device evaluation: product testing could not be performed since the device was not returned for evaluation.Therefore, the reported issue could not be verified, and product quality deficiency could not be determined.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search of complaints related to this production order (po) was performed.The search revealed that one additional complaint was received for this po.No escalation required.Conclusion: a product deficiency has not been identified; therefore, no additional corrective actions have been initiated.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the haptic got stuck in the injector during intraocular lens (iol) implantation.The lens was already inserted into the eye and the haptic became disconnected from the iol.The lens was extracted for replacement, but an anterior vitrectomy was required due to leakage.This lead to a choroidal bleed and excessive damage to the eye, resulting in no lens being implanted.The potential for a good outcome for vision are described as not good.The incision in the patient's eye was enlarged, sutures were required and there was a delay of 45 minutes to the procedure.Multiple medications were prescribed, both for intraocular pressure and the other symptoms.The patient is described as permanently impaired, with their daily activities significantly impacted.Their pre-operative vision was described as good with a cataract.Post-operative vision was close waving hand vision only.No further information was provided.

Manufacturer Narrative

Corrected information: section h6: during a file review on 13 june 2023, it was found that a code for incision enlarged was inadvertently omitted from the initial report, submitted on 26 may 2023 under report # 3012236936-2023-01262.Section h6 -health effect - clinical code: 4581: incision enlarged please note that the information reported in sections d2 (common device name), h.6 (health effect -clinical code and medical device problem code) and section g.1 (manufacturer contact e-mail) is information that remains unchanged from the initial emdr report.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS 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: 17015281
• MDR Text Key: 316106669
• Report Number: 3012236936-2023-01262
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474558045
• UDI-Public: (01)05050474558045(17)250909
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• Report Date: 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2022
• 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 Age: 80 YR
• Patient Sex: Female