Study: NCT04747834

Adverse event: Study Eye - Raised IOP Requiring Treatment
Serious: no
Organ System: Eye disorders
Notes: Seven subjects had raised Intraocular Pressure (IOP) requiring treatment. All subjects recovered from the AE with no sequelae.
Frequency: 5 affected / 44 at risk

Adverse event: Study Eye - Posterior Capsule Rupture
Serious: no
Organ System: Eye disorders
Notes: During the surgical procedure, the subject had a mild posterior capsule rupture. The investigator continued with the surgery, the event resolved without sequelae and was unrelated to the study device
Frequency: 1 affected / 44 at risk

Adverse event: Study Eye -Vitreal Prolapse
Serious: no
Organ System: Eye disorders
Notes: At 1 Month Postoperative, the subject had a vitreal prolapse. At 5 months postoperative, the vitreous strand was much improved, and the subject recovered with no sequelae
Frequency: 1 affected / 44 at risk

Adverse event: Study Eye - Cystoid Macular Edema
Serious: no
Organ System: Eye disorders
Notes: At 1 month postoperative, the subject presented with cystoid macular edema. The Subject was started on Prolensa OS BID and failed to return after the study completion date.
Frequency: 1 affected / 44 at risk

Adverse event: Study Eye - Increased Inflammation
Serious: no
Organ System: Eye disorders
Notes: At 6 weeks postoperative, the subject presented with Increased Inflammation in the study eye. The subject was prescribed an NSAID and the subject recovered with no sequalae.
Frequency: 1 affected / 44 at risk

Adverse event: Study Eye - Ectropion
Serious: no
Organ System: Eye disorders
Notes: At 2 Months postoperative the subject presented with an elevated punctal mass with ectropion left lower lid. At 3 months postop the subject underwent ectropion repair with the Oculoplastics surgeon, and the ectropion had resolved.
Frequency: 1 affected / 44 at risk

Adverse event: Study Eye - Dry Eye
Serious: no
Organ System: Eye disorders
Notes: Two subjects presented with postoperative dry eye. One of the subjects had their punctal plugs replaced and the AE resolved. The other subject also had the Ectropion AE which may have caused the dry eye, the dry eye AE resolved after surgery.
Frequency: 1 affected / 44 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Immune system disorders
Notes: At 1 month postoperative (8/23/21), the subject was hospitalized with pneumonia for 3 days. The event was serious, unrelated to the study device, and the subject was released from the hospital and fully recovered.
Frequency: 1 affected / 56 at risk

Adverse event: Study Eye - Raised IOP Requiring Treatment
Serious: no
Organ System: Eye disorders
Notes: Seven subjects had raised Intraocular Pressure (IOP) requiring treatment. All subjects recovered from the AE with no sequelae.
Frequency: 7 affected / 56 at risk

Adverse event: Study Eye - Dry Eye
Serious: no
Organ System: Eye disorders
Notes: Two subjects presented with postoperative dry eye. One of the subjects had their punctal plugs replaced and the AE resolved. The other subject also had the Ectropion AE which may have caused the dry eye, the dry eye AE resolved after surgery.
Frequency: 1 affected / 56 at risk

Adverse event: Study Eye - Corneal Edema
Serious: no
Organ System: Eye disorders
Notes: Two subjects had postop corneal edema. One of the subjects was prescribed Durezol and the event resolved. The other subject no action was taken and the event resolved by the next visit.
Frequency: 2 affected / 56 at risk

Adverse event: Study Eye - Crocodile Shagreen
Serious: no
Organ System: Eye disorders
Notes: At 1 month postoperative the subject was diagnosed with a mild case of Crocodile Shagreen in both eyes which was unrelated to the study device. The subject was prescribed medication and the event resolved 2 weeks later.
Frequency: 1 affected / 56 at risk

Adverse event: Study Eye - Microcystic Corneal Edema
Serious: no
Organ System: Eye disorders
Notes: At 1 month postoperative, the subject presented with cystoid macular edema and was prescribed medication. . The subject cancelled the 2-month appointment and withdrew consent from the study. There is no further follow up for this subject.
Frequency: 1 affected / 56 at risk

Adverse event: Study Eye - IOL Exchange
Serious: no
Organ System: Eye disorders
Notes: At 5-weeks postoperative, the subject was unable to tolerate the current IOL in the study eye and had an IOL exchange. At 2 months postoperative the subject had the IOL exchange which was uneventful, and the subject recovered with no sequelae.
Frequency: 1 affected / 56 at risk